66 FR 206 pgs. 53836-53927 - Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
Type: NOTICEVolume: 66Number: 206Pages: 53836 - 53927
Docket number: [Docket No. 98N-0046]
FR document: [FR Doc. 01-26650 Filed 10-23-01; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under 21 CFR 10.115(n)(2) of FDA's regulation on Good Guidance Practices (GGPs). This list is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.
DATES:
We welcome general comments on this list and on agency guidance documents at any time.
ADDRESSES:
Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov.dockets/ecomments. We have provided information in the tables below on where to obtain a single copy of any of the guidance documents listed.
FOR FURTHER INFORMATION CONTACT:
Carol A. Kimbrough, Office of Policy, Planning, and Legislation (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
We published our final rule on GGPs in the Federal Register of September 19, 2000 (65 FR 56468), and they became effective October 19, 2000. GGPs are intended to ensure involvement of the public in the development of guidance documents, and to enhance understanding of the availability, nature, and legal effect of such guidance. We committed in the GGPs to publishing annually a comprehensive list of guidance documents. This list updates a comprehensive list published July 21, 2000 (65 FR 45428).
The following comprehensive list identifies all final guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn this year are also listed. We have organized the documents by the issuing Center or Office within FDA, and we have identified the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing Center or Office maintains its own database, there are slight variations in the way in which they provide information on the tables below.
The following most frequently used Internet sites for agency guidances are provided for future reference:
CBER: http://www.fda.gov/cber/guidelines.htm
CDER: http://www.fda.gov/cder/guidance/index.htm
CDRH: http://www.fda.gov/cdrh/guidance.html
CFSAN: http://www.cfsan.fda.gov/dms/guidance.html
CVM: http://www.fda.gov/cvm/guidance/published.htm # documents
ORA: http://www.fda.gov/ora/compliance-;ref
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | How to Obtain a Hard Copy of the -Document |
|---|---|---|---|
| Interpretative Guidelines of the Source Plasma (Human) Standards | October 2, 1973 | FDA Regulated Industry | Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber |
| Guidelines for Reviewing Amendments to Include Plasmapheresis of Hemophiliacs | July 20, 1976 | Do | Do |
| Package Insert: Immune Serum Globulin (Human) | March 30, 1978 | Do | Do |
| Guidelines for Interpretation of Potency Test Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids | April 12, 1979 | Do | Do |
| Guidelines for Immunization of Source Plasma (Human) Donors With Blood Substances | June 1, 1980 | Do | Do |
| Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes) | January 28, 1981 | Do | Do |
| Platelet Testing Guidelines-Approval of New Procedures and Equipment | July 1, 1981 | Do | Do |
| Revised Guideline for Adding Heparin to Empty Containers for Collection of Heparinized Source Plasma (Human) | August 1, 1981 | Do | Do |
| Requirements for Infrequent Plasmapheresis Donors | August 27, 1982 | Do | Do |
| Recommendations to Decrease the Risk of Transmitting AIDS From Plasma Donors | March 24, 1983 | Do | Do |
| PTC in the Manufacture of In Vitro Monoclonal Antibody Products Subject to Licensure | June 20, 1983 | Do | Do |
| Draft PTC in the Production and Testing of Interferon Intended for Investigational Use in Humans (Interferon Test Procedures) | July 28, 1983 | Do | Do |
| Interstate Shipment of Interferon for Investigational Use in Laboratory Research Animals or Tests in Vitro | November 21, 1983 | Do | Do |
| Deferral of Blood Donors Who Have Received the Drug Accutane (Isotretinoin/Roche); 13-cis-retinoic acid) | February 28, 1984 | Do | Do |
| Equivalent Methods for Compatibility Testing | December 14, 1984 | Do | Do |
| Plasma Derived From Therapeutic Plasma Exchange | December 14, 1984 | Do | Do |
| Draft PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology | April 10, 1985 | Do | Do |
| Guidelines for Meningococcal Polysaccharide Vaccines | July 17, 1985 | Do | Do |
| Guideline for the Uniform Labeling of Blood and Blood Components | August 1, 1985 | Do | Do |
| Recommended Methods for Short Ragweed Pollen Extracts | November 1, 1985 | Do | Do |
| Reduction of the Maximum Platelet Storage Period to 5 Days in an Approved Container | June 2, 1986 | Do | Do |
| To In Vitro Diagnostic Reagent Manufacturers: Guidance on the Labeling of Human Blood Derived in Vitro Diagnostic Devices in Regard to Labeling for HTLV-III/LAV Antibody Testing | December 6, 1986 | Do | Do |
| Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics | February 1, 1987 | Do | Do |
| Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics | February 1, 1987 | Do | Do |
| Guideline on General Principles of Process Validation | May 1, 1987 | Do | Do |
| Guideline on Sterile Drug Products Produced by Aseptic Processing | June 1, 1987 | Do | Do |
| Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone | November 25, 1987 | Do | Do |
| Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices | December 1, 1987 | Do | Do |
| Recommendations for the Management of Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) | December 2, 1987 | Do | Do |
| Extension of Dating Period for Storage of Red Blood Cells, Frozen | December 4, 1987 | Do | Do |
| To Licensed In Vitro Diagnostic Manufacturers: Handling of Human Blood Source Materials | December 23, 1987 | Do | Do |
| Recommendations for Implementation of Computerization in Blood Establishments | April 6, 1988 | Do | Do |
| Control of Unsuitable Blood and Blood Components | April 6, 1988 | Do | Do |
| Discontinuance of Prelicensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines | July 7, 1988 | Do | Do |
| Physician Substitutes | August 15, 1988 | Do | Do |
| To Licensed Manufacturers of Blood Grouping Reagents: Criteria for Exemption of Lot Release | August 26, 1988 | Do | Do |
| Revised Guideline for the Collection of Platelets, Pheresis | October 7, 1988 | Do | Do |
| To Manufacturers of HTLV-I Antibody Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel I | October 18, 1988 | Do | Do |
| Draft Guideline for the Design of Clinical Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses | November 1, 1988 | Do | Do |
| HTLV-I Antibody Testing | November 29, 1988 | Do | Do |
| Use of Recombigen HIV-1 LA Test | February 1, 1989 | Do | Do |
| Guidelines for Release of Pneumococcal Vaccine, Polyvalent | February 1, 1989 | Do | Do |
| Guidance for Autologous Blood and Blood Components | March 15, 1989 | Do | Do |
| HTLV-I Antibody Testing | July 6, 1989 | Do | Do |
| Use of Recombigen HIV-1 Latex Agglutination (LA) Test | August 1, 1989 | Do | Do |
| Draft PTC in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989) | August 8, 1989 | Do | Do |
| PTC in the Collection, Processing and Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans | August 22, 1989 | Do | Do |
| Information Relevant to the Manufacture of Acellular Pertussis Vaccine | August 23, 1989 | Do | Do |
| FDA Regulated Industries for Drug Master Files | September 1, 1989 | Do | Do |
| Requirements for Computerization of Blood Establishments | September 8, 1989 | Do | Do |
| Abbott Laboratories' HIVAG-1 Test for HIV-1 Antigen(s) Not Recommended for Requirements for Computerization of Blood Establishments | October 4, 1989 | Do | Do |
| Guideline for Collection of Blood or Blood Products From Donors With PositiveTests for Infectious Disease Markers ("High Risk" Donors) | October 26, 1989 | Do | Do |
| Guideline for Determination of Residual Moisture in Dried Biological Products | January 1, 1990 | Do | Do |
| Autologous Blood Collection and Processing Procedures | February 12, 1990 | Do | Do |
| Cytokine and Growth Factor Pre-Pivotal Trial Information Package | April 2, 1990 | Do | Do |
| Use of Genetic Systems HIV-2 EIA | June 21, 1990 | Do | Do |
| PTC in the Safety Evaluation of Hemoglobin-Based Oxygen Carriers | August 21, 1990 | Do | Do |
| Guideline on the Preparation of Investigational New Drug Products (Human and Animal) | March 1, 1991 | Do | Do |
| FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica | March 15, 1991 | Do | Do |
| Revision to October 26, 1989, Guideline for Collection of Blood or Blood Products From Donors With Positive Tests for Infectious Disease Markers (High Risk Donors) | March 17, 1991 | Do | Do |
| Deficiencies Relating to the Manufacture of Blood and Blood Components | March 20, 1991 | Do | Do |
| Responsibilities of Blood Establishments Related to Errors and Accidents in the Manufacture of Blood and Blood Components | March 20, 1991 | Do | Do |
| To Biologic Product Manufacturers-Controlling Materials of Bovine or Ovine Origin | May 3, 1991 | Do | Do |
| FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) | September 10, 1991 | Do | Do |
| Disposition of Blood Products Intended for Autologous Use That Test Repeatedly Reactive for Anti-HCV | September 11, 1991 | Do | Do |
| Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing | December 12, 1991 | Do | Do |
| Recommended Methods for Blood Grouping Reagents Evaluation | March 1, 1992 | Do | Do |
| Recommended Methods for Evaluating Potency, Specificity and Reactivity of Anti-Human Globulin | March 1, 1992 | Do | Do |
| PTC in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin | March 1, 1992 | Do | Do |
| PTC in the Manufacture of In Vitro Monoclonal Antibody Products for Further Manufacturing into Blood Grouping Reagent and Anti-Human Globulin | March 1, 1992 | Do | Do |
| Supplement to the PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability | April 6, 1992 | Do | Do |
| Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products | April 23, 1992 | Do | Do |
| Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA) | April 23, 1992 | Do | Do |
| Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) | April 23, 1992 | Do | Do |
| Exemptions to Permit Persons With a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma; Alternative Procedures, 21 CFR 640.120 | April 23, 1992 | Do | Do |
| Changes in Equipment for Processing Blood Donor Samples | July 21, 1992 | Do | Do |
| Nomenclature for Monoclonal Blood Grouping Reagents | September 28, 1992 | Do | Do |
| Volume Limits for Automated Collection of Source Plasma | November 4, 1992 | Do | Do |
| FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics | November 25, 1992 | Do | Do |
| Revision of October 7, 1988, Memo Concerning Red Blood Cell Immunization Programs | December 16, 1992 | Do | Do |
| Draft PTC in the Characterization of Cell Lines Used to Produce Biologicals | July 12, 1993 | Do | Do |
| CBER Refusal to File (RTF) Guidance for Product and Establishment License Applications | July 12, 1993 | Do | Do |
| Guidance on Alternatives to Lot Release for Licensed Biological Products | July 20, 1993 | Do | Do |
| Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products | July 22, 1993 | Do | Do |
| Deferral of Blood and Plasma Donors Based on Medications | July 28, 1993 | Do | Do |
| Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) | August 19, 1993 | Do | Do |
| Changes in Administrative Procedures | September 9, 1993 | Do | Do |
| To Sponsors of INDs Using Retroviral Vectors | September 20, 1993 | Do | Do |
| Draft Guideline for the Validation of Blood Establishment Computer Systems | September 28, 1993 | Do | Do |
| Methods of the Allergenic Products Testing Laboratory | October 1, 1993 | Do | Do |
| Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice | October 14, 1993 | Do | Do |
| Guideline for Adverse Experience Reporting for Licensed Biological Products | October 15, 1993 | Do | Do |
| Guidance Regarding Post Donation Information Reports | December 10, 1993 | Do | Do |
| To Manufacturers: Bovine Derived Materials (BSE) | December 17, 1993 | Do | Do |
| Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis | December 22, 1993 | Do | Do |
| Compliance Program Guidance Manual (Drugs and Biologics) | 1994 | Do | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-605-6050 (NTIS Order No. 94-920699) |
| Recommendations for the Invalidation of Test Results When Using Licensed Viral Marker Assays to Screen Donors | January 3, 1994 | Do | Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber |
| To Sponsors of INDs for Human Immunoglobulin Products | May 23, 1994 | Do | Do |
| To Manufacturers of Licensed Anti-HIV Test Kits | May 26, 1994 | Do | Do |
| Recommendations for Deferral of Donors for Malaria Risk | July 26, 1994 | Do | Do |
| ICH Guideline for Industry: Studies in Support of Special Populations | August 1, 1994 | Do | Do |
| OELPS, Advertising and Promotional Labeling Staff Procedural Guidance Document (Draft) | August 1, 1994 | Do | Do |
| ICH Guideline for Industry: Stability Testing of New Drug Substances and Products | September 1, 1994 | Do | Do |
| Guide to Inspections of Blood Banks, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs | September 1, 1994 | FDA Personnel | Do |
| Letter to Manufacturers of Immune Globulin Intravenous (Human) (IGIV), Aseptic Meningitis Syndrome | October 3, 1994 | FDA Regulated Industry | Do |
| Guidance on Alternatives to Lot Release for Licensed Biological Products | October 27, 1994 | Do | Do |
| Guidance for Industry: For the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances | November 1994 | Do | Do |
| Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems | December 20, 1994 | Do | Do |
| To Manufacturers of Immune Globulin Products: Testing for Hepatitis C Virus RNA Immunoglobulin | December 27, 1994 | Do | Do |
| Timeframe for Licensing Irradiated Blood Products | February 3, 1995 | Do | Do |
| Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous Guidance | February 23, 1995 | Do | Do |
| ICH Guideline for Industry: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting | March 1, 1995 | Do | Do |
| To Manufacturers of Intramuscular Immune Globulin Products: HCV RNA Testing by PCR | March 3, 1995 | Do | Do |
| Revision of 8/27/82 FDA Memo: Requirements for Infrequent Plasmapheresis Donors | March 10, 1995 | Do | Do |
| To Manufacturers of Intramuscular Immune Globulin Products: Additional Information Regarding HCV RNA Testing by PCR | March 13, 1995 | Do | Do |
| To Health Professionals: Implementation of Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular Administration | March 14, 1995 | Do | Do |
| To All Establishments Performing Red Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma | March 14, 1995 | Do | Do |
| Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source Plasma | June 8, 1995 | Do | Do |
| Guideline for Quality Assurance in Blood Establishments | July 11, 1995 | Do | Do |
| FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products | July 11, 1995 | Do | Do |
| Disposition of Products Derived From Donors Diagnosed With, or at Known High Risk for, Creutzfeldt-Jakob Disease | August 8, 1995 | Do | Do |
| Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained From Donors With Elevated Levels of Alanine Aminotransferase (ALT) | August 8, 1995 | Do | Do |
| Precautionary Measures to Further Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease by Blood and Blood Products | August 8, 1995 | Do | Do |
| Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen | August 8, 1995 | Do | Do |
| PTC in the Manufacture and Testing of Therapeutic Products for Human Use Derived From Transgenic Animals | August 22, 1995 | Do | Do |
| Informed Consent for Plasmapheresis/Immunization | October 1, 1995 | FDA Personnel | Do |
| Draft Reviewers' Guide: Changes in Personnel | October 1, 1995 | FDA Personnel | Do |
| Disease Associated Antibody Collection Program | October 1, 1995 | FDA Personnel | Do |
| Guidance Concerning Conversion to FDA-Reviewed Software Products | November 13, 1995 | FDA Regulated Industry | Do |
| Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis | December 4, 1995 | Do | Do |
| Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products | December 8, 1995 | Do | Do |
| Dear Colleague: Regarding Reverse Transcriptase Activity in Viral Vaccines Produced in Chicken Cells | January 4, 1996 | Do | Do |
| Requesting All Manufacturers Immediately to Revise Warning Section for Package Insert on Thrombin | January 4, 1996 | Do | Do |
| ICH Final Guideline: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Dervied Protein Products | February 23, 1996 | Do | Do |
| ICH Final Guideline on the Need for Long-Term Rodent Carcinogenicity Study of Pharmaceuticals | March 1, 1996 | Do | Do |
| Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen | March 14, 1996 | Do | Do |
| FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products | March 26, 1996 | Do | Do |
| ICH Guideline on the Detection of Toxicity to Reproduction for Medicinal Products; Addendum on Toxicity to Male Fertility | April 5, 1996 | Do | Do |
| ICH Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals | April 24, 1996 | Do | Do |
| To Manufacturers of FDA-Regulated Drug/Biological/Device Products, Bovine Spongiform Encephalopathy (BSE) | May 9, 1996 | Do | Do |
| Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) | May 16, 1996 | Do | Do |
| Guidance for Industry-The Content and Format for Pediatric Use Supplements | May 23, 1996 | Do | Do |
| Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of Reconstruction | May 24, 1996 | Do | Do |
| Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products | May 29, 1996 | Do | Do |
| Guide to Inspections of Infectious Disease Marker Testing Facilities | June 1, 1996 | FDA Personnel | Do |
| To Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Polymerase Chain Reaction (PCR) of Intramuscular Immune Globulin Preparations | June 13, 1996 | FDA Regulated Industry | Do |
| ICH Final Guidelines on Stablity Testing of Biotechnological/Biological Products | July 10, 1996 | ||
| ICH Guideline on Structure and Content of Clinical Study Reports | July 17, 1996 | Do | Do |
| Recommendations for the Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I) | July 19, 1996 | Do | Do |
| To Manufacturers: HIV-1 Group O | July 31, 1996 | Do | Do |
| Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use | August 15, 1996 | Do | Do |
| ICH Revised Guidance: Single Dose Acute Toxicity Testing for Pharmaceuticals | August 26, 1996 | Do | Do |
| ICH Draft Guideline on Data Elements for Transmission of Individual Case Reports | October 1, 1996 | Do | Do |
| To All Plasma Derivative Manufacturers and to ABRA: Warning Statement for Plasma Derivative Product Labeling | October 7, 1996 | Do | Do |
| Advertising and Promotion; Guidance; Notice | October 8, 1996 | Do | Do |
| To Biologic Product Manufacturers: Revised Procedures for Internal Labeling Review Number Assignment | December 3, 1996 | Do | Do |
| Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection | December 11, 1996 | Do | Do |
| PTC on Plasmid DNA Vaccines for Preventive Infectious Disease Indications | December 22, 1996 | Do | Do |
| Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products | January 1997 | Do | Do |
| Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software | January 13, 1997 | FDA Personnel | Do |
| PTC in the Manufacturing and Testing of Monoclonal Antibody Products for Human Use | February 28, 1997 | Do | Do |
| Proposed Approach to Regulation of Cellular and Tissue-Based Products | February 27, 1997 | Do | Do |
| Tables 1 and 2 From Proposed Approach to Regulation of Cellular and Tissue-Based Products | March 4, 1997 | Do | Do |
| Preclearance of Promotional Labeling; Clarification | March 5, 1997 | Do | Do |
| Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies | April 1997 | Do | Do |
| ICH Draft Guideline on Dose Selection for Carcinogenicity Studies for Pharmaceuticals: Addendum on the Limit Dose | April 2, 1997 | Do | Do |
| ICH Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals | May 2, 1997 | Do | Do |
| ICH Draft Guideline on Impurities: Residual Solvents | May 2, 1997 (Correction May 19, 1997) | Do | Do |
| ICH Guideline on Stability Testing for New Dosage Forms | May 9, 1997 | Do | Do |
| ICH Draft Guideline on Statistical Principles for Clinical Trials, Part III | May 9, 1997 | Do | Do |
| ICH Good Clinical Practice: Consolidated Guideline, Part II | May 9, 1997 | Do | Do |
| ICH Guideline for the Photostability Testing of New Drug Substances and Products, Part II | May 16, 1997 | Do | Do |
| ICH Guideline on Impurities in New Drug Products, Part IV | May 19, 1997 | Do | Do |
| ICH Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, Part VI | May 19, 1997 | Do | Do |
| ICH Guideline on the Validation of Analytical Procedures: Methodology, Part V | May 19, 1997 | Do | Do |
| To Plasma Fractionators-CBER's View on Product Recalls Conducted by the Plasma Fractionation Industry | May 29, 1997 | Do | Do |
| ICH Draft Guideline on General Considerations for Clinical Trials | May 30, 1997 | Do | Do |
| Guide to Inspections of Source Plasma Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs) | June 1, 1997 | FDA Personnel | Do |
| Draft Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability | June 18, 1997 | FDA Regulated Industry | Do |
| Guidance for Industry-Changes to an Approved Application: Biological Products | July 1997 | Do | Do |
| Guidance for Industry-Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products | July 1997 | Do | Do |
| Guidance for Industry-Screening and Testing of Donors of Human Tissue Intended for Transplantation | July 1997 | Do | Do |
| Guidance for Industry-Donor Screening for Antibodies to HTLV-II | August 1997 | Do | Do |
| Guidance for Industry-Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report | August 1997 | Do | Do |
| Draft Guidance for Industry Efficacy Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers | September 1997 | Do | Do |
| Guidance for Industry-The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use | September 1997 | Do | Do |
| Notification Process for Transfusion Related Fatalities and Donation Related Deaths (revised telephone number) | October 7, 1997 | Do | Do |
| Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries | October 15, 1997 | Do | Do |
| ICH Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals | November 18, 1997 | Do | Do |
| ICH Guidance on Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals | November 21, 1997 | Do | Do |
| ICH Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals | November 25, 1997 | Do | Do |
| Guidance for FDA and Industry: Direct Final Rule Procedures | November 21, 1997 | FDA Personnel and Regulated Industry | Do |
| Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS) | December 1997 | FDA Regulated Industry | Do |
| Guidance for Industry: Industry-Supported Scientific and Educational Activities | December 3, 1997 | Do | Do |
| ICH Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes | December 4, 1997 | Do | Do |
| To Biologic Product Manufacturers-Withdrawal of Human Blood-Derived Materials Because Donors Diagnosed With, or at Increased Risk for, CJD | December 11, 1997 | Do | Do |
| To Allergenic Extract Manufacturers-Standardized Grass Pollen Extracts | December 23, 1997 | Do | Do |
| ICH Guidance on Data Elements for Transmission of Individual Case Safety Reports | January 15, 1998 | ||
| Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products | January 1998 | Do | Do |
| Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products | January 1998 | Do | Do |
| ICH Guidance on Testing for Carcinogenicity of Pharmaceuticals | February 28, 1998 | ||
| Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients | March 1998 | Do | Do |
| Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy | March 1998 | Do | Do |
| Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research | May 1998 | Do | Do |
| Draft Guidance for Industry: Pilot Program for Electronic Investigational New Drug (eIND) Applications for Biological Products | May 1998 | Do | Do |
| Guidance for Industry: Classifying Resubmissions in Response to Action Letters | May 1998 | Do | Do |
| Guidance for Industry: Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis and Impact on Dosing and Labeling | May 1998 | Do | Do |
| Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements | May 1998 | Do | Do |
| Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products | May 1998 | Do | Do |
| Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products | June 1998 | Do | Do |
| Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act | June 1998 | Do | Do |
| Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing | June 1998 | Do | Do |
| ICH Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | June 9, 1998 | Do | Do |
| ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data | June 10, 1998 | Do | Do |
| Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 | June 12, 1998 | Do | Do |
| Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997-Elimination of Certain Labeling Requirements | July 1998 | Do | Do |
| Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications | July 1998 | Do | Do |
| Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV | September 1998 | Do | Do |
| Draft Guidance for Industry: Submitting Debarment Certification Statements | September 1998 | Do | Do |
| Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1) | September 1998 | Do | Do |
| Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review | September 1998 | Do | Do |
| ICH Guidance on Statistical Principles for Clinical Trials | September 16, 1998 | Do | Do |
| ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products | September 21, 1998 | Do | Do |
| ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin | September 24, 1998 | Do | Do |
| Guidance for Industry: On Advisory Committees: Implementing Section 120 of the Food and Drug Administration Act of 1997 | October 1998 | Do | Do |
| Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products | November 1998 | Do | Do |
| To Viral Vaccine IND Sponsors-Use of PCR-Based Reverse Transcriptase Assay | December 18, 1998 | Do | Do |
| Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products | December 1998 | Do | Do |
| Draft Guidance for Industry: Content and Format of Geriatric Labeling | December 1998 | Do | Do |
| Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional Labeling | January 1999 | Do | Do |
| Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product | January 1999 | Do | Do |
| Guidance on Amended Procedures for Advisory Panel Meetings | January 1999 | Do | Do |
| Guidance for Industry: Providing Regulatory Submissions in Electronic Format-General Considerations | January 1999 | Do | Do |
| Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products | February 1999 | Do | Do |
| Guidance for Industry: Population Pharmacokinetics | February 1999 | Do | Do |
| Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA) | February 1999 | Do | Do |
| Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products | February 1999 | Do | Do |
| Draft Guidance for Industry: INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufacturing and Controls Content and Format | February 1999 | Do | Do |
| Draft Guidance for Industry: Accelerated Approval Products-Submission of Promotional Materials | March 1999 | Do | Do |
| Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product | March 1999 | Do | Do |
| Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans | April 1999 | Do | Do |
| Guidance for Industry on the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test | April 1999 | Do | Do |
| Guidance for Industry for the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h "Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use" | May 1999 | Do | Do |
| Guidance for Industry for Platelet Testing and Evaluation of Platelet Substitute Products | May 1999 | Do | Do |
| Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use | May 1999 | Do | Do |
| Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation | May 1999 | Do | Do |
| Draft Guidance for Industry: Establishing Pregnancy Registries | June 1999 | Do | Do |
| Draft Reviewer Guidance: Evaluation of Human Pregnancy Outcome Data | June 1999 | FDA Personnel | Do |
| Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV) | June 1999 | FDA Regulated Industry | Do |
| ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) | June 25, 1999 | Do | Do |
| Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) | July 1999 | Do | Do |
| Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations | July 1999 | Do | Do |
| Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics | August 1999 | Do | Do |
| Guidance for Industry: Consumer-Directed Broadcast Advertisements | August 1999 | Do | Do |
| Draft Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act | August 1999 | Do | Do |
| Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products | August 1999 | Do | Do |
| Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications | August 1999 | Do | Do |
| ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | August 18, 1999 | Do | Do |
| Draft Guidance for Industry: Revised Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors | September 1999 | Do | Do |
| Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act | September 1999 | Do | Do |
| International Conference on Harmonisation Draft Guidance; Choice of Control Group in Clinical Trials | September 24, 1999 | Do | Do |
| Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format-Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]-Revised | November 1999 | Do | Do |
| Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products | November 1999 | Do | Do |
| Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies-Study Design, Data Analysis and Recommendations for Dosing and Labeling | November 1999 | Do | Do |
| Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma | November 1999 | Do | Do |
| Draft Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis and Impact on Dosing and Labeling | November 1999 | Do | Do |
| International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common Technical Document | November 8, 1999 | Do | Do |
| Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 | December 1999 | Do | Do |
| Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Contacts | December 1999 | Do | Do |
| Draft Guidance for Industry: Special Protocol Assessment | December 1999 | Do | Do |
| Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture | January 2000 | Do | Do |
| Draft Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol | February 2000 | FDA Personnel | Do |
| Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information | February 2000 | FDA Regulated Industry | Do |
| Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products | February 2000 | Do | Do |
| Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level | February 2000 | Do | Do |
| Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing | February 2000 | Do | Do |
| Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank | March 2000 | Do | Do |
| International Conference on Harmonisation; Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products | April 21, 2000 | Do | Do |
| Draft Guidance for Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics | May 2000 | Do | Do |
| Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components | June 2000 | Do | Do |
| Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria | June 2000 | Do | Do |
| Draft Guidance for Industry: Pediatric Oncology Studies in Response to a Written Request | June 2000 | Do | Do |
| Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use With Cadaveric Blood Specimens (Level 2) | June 2000 | Do | Do |
| Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment | June 2000 | Do | Do |
| Draft Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside Supplier | June 2000 | Do | Do |
| Draft Guidance for Industry: Developing Medical Imaging Drugs and Biological Products | June 2000 | Do | Do |
| International Conference on Harmonisation (ICH) Draft Guidance; Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (March 17, 2000) | June 2000 | Do | Do |
| International Conference on Harmonisation (ICH) Draft Revised Guidance on Impurities in New Drug Products | July 19, 2000 | Do | Do |
| International Conference on Harmonisation (ICH) Draft Revised Guidance on Impurities in New Drug Substances | July 20, 2000 | Do | Do |
| International Conference on Harmonisation (ICH) Draft Guideline: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use | July 20, 2000 | Do | Do |
| International Conference on Harmonisation (ICH) Draft Guideline on Safety Pharmacology Studies for Human Pharmaceuticals | August 2000 | Do | Do |
| Draft Guidance for Industry: Analytical Procedures and Methods Validation-Chemistry, Manufacturing, and Controls Documentation | August 2000 | Do | Do |
| Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications | August 2000 | Do | Do |
| Guidance for Industry: Q A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products | October 2000 | Do | Do |
| Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors | October 2000 | Do | Do |
| Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds | October 2000 | Do | Do |
| Draft Guidance for Industry: Cancer Drug and Biological Products-Clinical Data in Marketing Applications | November 2000 | Do | Do |
| Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts | November 2000 | Do | Do |
| Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices (Level 2) | November 2000 | Do | Do |
| Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) | November 2000 | Do | Do |
| International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population | December 2000 | Do | Do |
| Draft Guidance for Industry: Variances for Blood Collection From Individuals With Hereditary Hemochromatosis | December 2000 | Do | Do |
| Draft Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees | December 2000 | Do | Do |
| International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances | December 29, 2000 | Do | Do |
| PHS Guideline on Infectious Disease Issues in Xenotransplantation | January 19, 2001 | Do | Do |
| Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion | January 2001 | Do | Do |
| Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods | January 2001 | Do | Do |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Prescription Drug Advertising and Promotional Labeling | January 2001 | Do | Do |
| Draft Guidance for Industry: Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans | February 2001 | Do | Do |
| Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods-Technical Correction February 2001 | February 2001 | Do | Do |
| Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research | February 2001 | Do | Do |
| Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines | March 2001 | Do | Do |
| Guidance for Industry: Acceptance of Foreign Clinical Studies | March 2001 | Do | Do |
| Guidance for Industry: Financial Disclosure by Clinical Investigators | March 2001 | Do | Do |
| Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing | March 2001 | Do | Do |
| Draft Guidance for Industry: Reports on the Status of Postmarketing Studies-Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 | April 2001 | Do | Do |
| Draft Guidance for Industry: Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements | April 2001 | Do | Do |
| Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution | April 2001 | Do | Do |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Postmarketing Expedited Safety Reports | May 2001 | Do | Do |
| Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials | May 2001 | Do | Do |
| Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information | May 2001 | Do | Do |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | How to Obtain a Hard Copy of the -Document |
|---|---|---|---|
| Accelerated Approval Products-Submission of Promotional Materials-Draft | March 26, 1999 | Advertising Draft | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Product Name, Placement, Size, and Prominence in Advertising and Promotional Labeling-Draft | March 12, 1999 | Do | Do |
| Promoting Medical Products in a Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies-Draft | January 5, 1998 | Do | Do |
| Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements-Draft | April 23, 2001 | Do | Do |
| Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling | January 12, 1998 | Advertising | Do |
| Consumer-Directed Broadcast Advertisements | August 9, 1999 | Do | Do |
| Industry-Supported Scientific and Educational Activities | December 3, 1997 | Do | Do |
| Antifungal (Topical)-Draft | February 24, 1990 | Biopharmaceutic Draft | Do |
| Antifungal (Vaginal)-Draft | February 24, 1990 | Do | Do |
| Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action-Draft | June 2, 1999 | Do | Do |
| Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence-Draft | March 9, 2000 | Do | Do |
| Food-Effect Bioavailability and Bioequivalence Studies-Draft | December 30, 1997 | Do | Do |
| In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies-Draft | December 10, 1997 | Do | Do |
| Topical Dermatological Drug Product NDAs and ANDAs-In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies-Draft | June 18, 1998 | Do | Do |
| Bioanalytical Method Validation | May 23, 2001 | Biopharmaceutic | Do |
| Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations | October 27, 2000 | Do | Do |
| Cholestyramine Powder In Vitro Bioequivalence | July 15, 1993 | Do | Do |
| Clozapine (Tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing | November 15, 1996 | Do | Do |
| Corticosteroids, Detmatologic (Topical) In Vivo | June 2, 1995 | Do | Do |
| Dissolution Testing of Immediate Release Solid Oral Dosage Forms | August 25, 1997 | Do | Do |
| Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations | September 26, 1997 | Do | Do |
| Levothyroxine Sodium Tablets-In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing | March 8, 2001 | Do | Do |
| Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro | June 27, 1989 | Do | Do |
| Phenytoin/Phenytion Sodium (Capsules, Tablets, Suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing | March 4, 1994 | Do | Do |
| Potassium Chloride (Slow-Release Tablets and Capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing | June 6, 1994 | Do | Do |
| Statistical Approaches to Establishing Bioequivalence | February 2, 2001 | Do | Do |
| Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System | August 31, 2000 | Do | Do |
| Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation-Draft | August 30, 2000 | Chemistry Draft | Do |
| Botanical Drug Products-Draft | August 11, 2000 | Do | Do |
| INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufacturing, and Controls Content and Format-Draft | April 20, 1999 | Do | Do |
| Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation-Draft | November 19, 1998 | Do | Do |
| Monoclonal Antibodies Used as Reagents in Drug Manufacturing-Draft | June 24, 1999 | Do | Do |
| Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products-Draft | June 2, 1999 | Do | Do |
| Stability Testing of Drug Substances and Drug Products-Draft | June 8, 1998 | Do | Do |
| Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications-Draft | November 1, 1991 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum-Draft | January 5, 1999 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Tracking of NDA and NDA Reformulations for Solid, Oral, Immediate Release Drug Products-Draft | April 12, 1989 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| BACPAC1: Intermediates in Drug Substance Synthesis: Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation | February 16, 2001 | Chemistry | Do |
| Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products | July 24, 1997 | Do | Do |
| Changes to an Approved NDA or ANDA | November 23, 1999 | Do | Do |
| Changes to an Approved NDA or ANDA: Questions and Answers | January 22, 2001 | Do | Do |
| Container Closure Systems for Packaging Human Drugs and Biologics | July 7, 1999 | Do | Do |
| Development of New Stereoisomeric Drugs | May 1, 1992 | Do | Do |
| Drug Master Files | September 1, 1989 | Do | Do |
| Drug Master Files for Bulk Antibiotic Drug Substances | November 29, 1999 | Do | Do |
| Environmental Assessment of Human Drugs and Biologics Applications | July 27, 1998 | Do | Do |
| Format and Content for the CMC Section of an Annual Report | September 1, 1994 | Do | Do |
| Format and Content of the Chemistry, Manufacturing and Controls Section of an Application | February 1, 1987 | Do | Do |
| Format and Content of the Microbiology Section of an Application | February 1, 1987 | Do | Do |
| IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information | May 25, 2001 | Do | Do |
| Monoclonal Antibodies Used as Reagents in Drug Manufacturing | March 29, 2001 | Do | Do |
| NDAs: Impurities in Drug Substances | February 25, 2000 | Do | Do |
| PAC-ALTS: Postapproval Changes-Analytical Testing Laboratory Sites | April 28, 1998 | Do | Do |
| Reviewer Guidance: Validation of Chromatographic Methods | November 1, 1994 | Do | Do |
| Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances | November 1, 1994 | Do | Do |
| Submission of Documentation for Sterilization Process Validation Applications for Human and Veterinary Drug Products | November 1, 1994 | Do | Do |
| Submitting Documentation for the Manufacturing of and Controls for Drug Products | February 1, 1987 | Do | Do |
| Submitting Documentation for the Stability of Human Drugs and Biologics | February 1, 1987 | Do | Do |
| Submitting Samples and Analytical Data for Methods Validation | February 1, 1987 | Do | Do |
| Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products | February 1, 1987 | Do | Do |
| Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances | February 1, 1987 | Do | Do |
| SUPAC IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation | November 30, 1995 | Do | Do |
| SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum | February 26, 1999 | Do | Do |
| SUPAC-IR: Questions and Answers | February 18, 1997 | Do | Do |
| SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation | October 6, 1997 | Do | Do |
| SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation | June 13, 1997 | Do | Do |
| The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy | December 20, 2000 | Do | Do |
| Acute Bacterial Exacerbation of Chronic Bronchitis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Clinical Antimicrobial Draft | Do |
| Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Acute Bacterial Sinusitis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Acute Otitis Media; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Catheter-Related Bloodstream Infections-Developing Antimicrobial Drugs for Treatment-Draft | October 18, 1999 | Do | Do |
| Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements-Draft | September 1, 1999 | Do | Do |
| Community Acquired Pneumonia; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Complicated Urinary Tract Infections and Pylonephritis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Developing Antimicrobial Drugs-General Considerations for Clinical Trials-Draft | July 22, 1998 | Do | Do |
| Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products-Draft | February 17, 1997 | Do | Do |
| Lyme Disease; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Nosocomial Pneumonia; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Secondary Bacterial Infections of Acute Bronchitis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Uncomplicated and Complicated Skin and Skin Structure Infections; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Uncomplicated Gonorrhea-Cervical, Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment-Draft | July 22, 1998 | Do | Do |
| Clinical Development and Labeling of Anti-Infective Drug Products | October 26, 1992 | Clinical Antimicrobial | Do |
| Clinical Evaluation of Anti-Infective Drugs (Systemic) | September 1, 1977 | Do | Do |
| Preclinical Development of Antiviral Drugs | November 1, 1990 | Do | Do |
| Abuse Liability Assessment-Draft | July 1, 1990 | Clinical Medical Draft | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Allergic Rhinitis: Clinical Development Programs for Drug Products-Draft | June 21, 2000 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Cancer Drug and Biological Products-Clinical Data in Marketing Applications-Draft | November 9, 2000 | Do | Do |
| Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment-Draft | June 28, 2000 | Do | Do |
| Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)-Draft | July 15, 1999 | Do | Do |
| Clinical Evaluation of Anti-Anginal Drugs-Draft | January 1, 1989 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Clinical Evaluation of Anti-Arrhythmic Drugs-Draft | July 1, 1985 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Clinical Evaluation of Antihypertensive Drugs-Draft | May 1, 1988 | Do | Do |
| Clinical Evaluation of Drugs for the Treatment of Congestive Heart Failure-Draft | December 1, 1987 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Clinical Evaluation of Drugs for Ulcerative Colitis (3rd draft)-Draft | January 7, 1991 | Do | Do |
| Clinical Evaluation of Lipid-Altering Agents In Adults and Children-Draft | September 1, 1990 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Clinical Evaluation of Motility-Modifying Drugs-Draft | Date not available | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Clinical Evaluation of Weight-Control Drugs-Draft | September 24, 1996 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Developing Medical Imaging Drugs and Biologics-Revised-Draft | July 31, 2000 | Do | Do |
| Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use Disorders-Draft | February 12, 1992 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Development of Parathyroid Hormones for the Prevention and Treatment of Osteoporosis-Draft | June 14, 2000 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Establishing Pregnancy Registries-Draft | June 4, 1999 | Do | Do |
| Evaluation of Human Pregnancy Outcome Data-Draft | June 4, 1999 | Do | Do |
| Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment-Draft | May 19, 2000 | Do | Do |
| Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research-Draft | March 30, 2000 | Do | Do |
| OTC Treatment of Herpes Labialis With Antiviral Agents-Draft | March 8, 2000 | Do | Do |
| Pediatric Oncology Studies in Response to a Written Request-Draft | June 21, 2000 | Do | Do |
| Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines-Draft | March 12, 2001 | Do | Do |
| Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis-Draft | April 1, 1994 | Do | Do |
| Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals-Draft | September 1, 1991 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Recommendations for Complying With the Pediatric Rule-Draft | December 4, 2000 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| System Inflammatory Response Syndrome (SIRS) (1st draft)-Draft | July 1993 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Acceptance of Foreign Clinical Studies | March 13, 2001 | Clinical Medical | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) | February 17, 1999 | Do | Do |
| Clinical Development Programs for MDI and DPI Drug Products | September 19, 1994 | Do | Do |
| Clinical Evaluation of Analgesic Drugs | December 1, 1992 | Do | Do |
| Clinical Evaluation of Antacid Drugs | April 1, 1978 | Do | Do |
| Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (Adults and Children) | April 1, 1988 | Do | Do |
| Clinical Evaluation of Antianxiety Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Antidepressant Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Antidiarrheal Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Antiepileptic Drugs (Adults and Children) | January 1, 1981 | Do | Do |
| Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women | March 20, 1995 | Do | Do |
| Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of General Anesthetics | May 1, 1982 | Do | Do |
| Clinical Evaluation of Hypnotic Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Laxative Drugs | April 1, 1978 | Do | Do |
| Clinical Evaluation of Local Anesthetics | May 1, 1982 | Do | Do |
| Clinical Evaluation of Psychoactive Drugs in Infants and Children | July 1, 1979 | Do | Do |
| Clinical Evaluation of Radiopharmaceutical Drugs | October 1, 1981 | Do | Do |
| Content and Format for Pediatric Use Supplements | May 24, 1996 | Do | Do |
| Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products | November 20, 1995 | Do | Do |
| Development of Vaginal Contraceptive Drugs (NDA) | April 19, 1995 | Do | Do |
| FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products | February 2, 1999 | Do | Do |
| FDA Requirements for Approval of Drugs to Treat Non-Small Lung Cancer | January 29, 1991 | Do | Do |
| FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer | June 20, 1989 | Do | Do |
| Format and Content of the Clinical and Statistical Sections of an Application | July 1, 1988 | Do | Do |
| Format and Content of the Summary for New Drug and Antibiotic Applications | February 1, 1987 | Do | Do |
| Formatting, Assembling and Submitting New Drug and Antibiotic Applications | February 1, 1987 | Do | Do |
| General Considerations for the Clinical Evaluation of Drugs | December 1, 1978 | Do | Do |
| General Considerations for the Clinical Evaluation of Drugs in Infants and Children | September 1, 1977 | Do | Do |
| Levothyroxine Sodium Tablets-In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing | March 8, 2001 | Do | Do |
| Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer | April 13, 1988 | Do | Do |
| Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer | April 19, 1988 | Do | Do |
| Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products; Clarification of What to Report | August 27, 1997 | Do | Do |
| Postmarketing Reporting of Adverse Drug Experiences | March 1, 1992 | Do | Do |
| Preclinical Development of Immunomodulatory Drugs for the Treatment of HIV Infection and Associated Disorders | September 4, 1992 | Do | Do |
| Preparation of Investigational New Drug Products (Human and Animal) | November 1, 1992 | Do | Do |
| Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products | May 15, 1998 | Do | Do |
| Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs | July 22, 1993 | Do | Do |
| Study of Drugs Likely To Be Used in the Elderly | November 1, 1989 | Do | Do |
| Submission of Abbreviated Reports and Synopses in Support of Marketing Applications | September 13, 1999 | Do | Do |
| General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products-Draft | November 30, 1998 | Clinical Pharmacology Draft | Do |
| Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling-Draft | December 7, 1999 | Do | Do |
| Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro | April 7, 1997 | Clinical Pharmacology | Do |
| Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application | February 1, 1987 | Do | Do |
| In Vivo Metabolism/Drug Interaction Studies-Study Design, Data Analysis, and Recommendations for Dosing and Labeling | November 24, 1999 | Do | Do |
| Pharmacokinetics and Pharmacodynamics in Patients With Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling | May 15, 1998 | Do | Do |
| Population Pharmacokinetics | February 10, 1999 | Do | Do |
| Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24)-Draft | March 30, 2000 | Compliance Draft | Do |
| Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production-Draft | September 30, 1998 | Do | Do |
| Manufacture, Processing or Holding of Active Pharmaceutical Ingredients-Draft | April 17, 1998 | Do | Do |
| Repacking of Solid Oral Dosage Form Drug Products-Draft | February 1, 1992 | Do | Do |
| A Review of FDA's Implementation of the Drug Export Amendments of 1986 | Compliance | Do | |
| Compressed Medical Gases | December 1, 1989 | Do | Do |
| Computerized Systems Used in Clinical Trials | May 10, 1999 | Do | Do |
| Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron | June 27, 1997 | Do | Do |
| General Principles of Process Validation | May 1, 1987 | Do | Do |
| Good Laboratory Practice Regulations Questions and Answers | Do | Do | |
| Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities | April 6, 2001 | Do | Do |
| Monitoring of Clinical Investigations | January 1, 1988 | Do | Do |
| Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment | May 1, 1984 | Do | Do |
| Possible Dioxin/PCB Contamination of Drug and Biological Products | August 23, 1999 | Do | Do |
| Sterile Drug Products Produced by Aseptic Processing | May 1, 1987 | Do | Do |
| Street Drug Alternatives | April 3, 2000 | Do | Do |
| Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices | December 1, 1987 | Do | Do |
| Providing Regulatory Submissions in Electronic Format-Postmarketing Expedited Safety Reports-Draft | May 4, 2001 | Electronic Submission Draft | Do |
| Providing Regulatory Submissions in Electronic Format: Prescription Drug Advertising and Promotional Labeling-Draft | January 31, 2001 | Do | Do |
| Preparing Data for Electronic Submissions in ANDAs | September 23, 1999 | Electronic Submission | Do |
| Regulatory Submissions in Electronic Format; General Considerations | January 28, 1999 | Do | Do |
| Regulatory Submissions in Electronic Format; New Drug Applications | January 28, 1999 | Do | Do |
| ANDAs; Blend Uniformity Analysis-Draft | August 26, 1999 | Generic Drug Draft | Do |
| ANDAs; Impurities in Drug Products-Draft | January 5, 1999 | Do | Do |
| Content and Format of an Abbreviated New Drug Application (ANDA)-Positron Emission Tomography (PET) Drug Products-With Specific Information for ANDAs for Fludeoxyglucose F18 Injection-Draft | April 18, 1997 | Do | Do |
| Alternate Source of Active Pharmaceutical Ingredients in Pending ANDAs-Draft | December 12, 2000 | Do | Do |
| ANDAs: Impurities in Drug Substances | December 3, 1999 | Generic Drugs | Do |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act | March 30, 2000 | Do | Do |
| Letter Announcing That the OGD Will Now Accept the ICH Long-Term Storage Conditions as Well as the Stability Studies Conducted in the Past | August 18, 1995 | Do | Do |
| Letter Describing Efforts by CDER and ORA to Clarify the Responsibilities of CDER Chemistry Review Scientists and ORA Field Investigators in the New and Abbreviated Drug Approval Process in Order to Reduce Duplication or Redundancy in the Process | October 14, 1994 | Do | Do |
| Letter on Incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations From OGD Policy | April 8, 1994 | Do | Do |
| Letter on the Provision of New Information Pertaining to New Bioequivalence Guidelines and Refuse-to-File Letters | July 1, 1992 | Do | Do |
| Letter on the Provision of New Procedures and Policies Affecting the Generic Drug Review Process | March 15, 1989 | Do | Do |
| Letter on the Request for Cooperation of Regulated Industry to Improve the Efficiency and Effectiveness of the Generic Drug Review Process, by Assuring the Completeness and Accuracy of Required Information and Data Submissions | November 8, 1991 | Do | Do |
| Letter on the Response to 12/20/84 Letter From the Pharmaceutical Manufacturers Association About the Drug Price Competition and Patent Term Restoration Act | March 26, 1985 | Do | Do |
| Letter to all ANDA and AADA Applicants About the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to Refuse-to-File Incomplete Submissions as Required by the New Law | January 15, 1993 | Do | Do |
| Letter to Regulated Industry Notifying Interested Parties About Important Detailed Information Regarding Labeling, Scale-up, Packaging, Minor/major Amendment Criteria, and Bioequivalence Requirements | August 4, 1993 | Do | Do |
| Major, Minor, Facsimile, and Telephone Amendments to Original Abbreviated New Drug Applications (Revised) | May 1, 2000 | Do | Do |
| Organization of an ANDA | March 2, 1999 | Do | Do |
| Revising ANDA Labeling Following Revision of the RLD Labeling | April 25, 2000 | Do | Do |
| Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products | February 3, 2000 | Do | Do |
| Variations in Drug Products That May Be Included ANDA | January 27, 1999 | Do | Do |
| Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review-Draft | November 22, 1996 | Good Review Practices Draft | Do |
| Pharmacology/Toxicology Review Format | May 10, 2001 | Good Review Practices | Do |
| Q1A(R)-Stability Testing of New Drug Substances and Products-Draft | April 21, 2000 | ICH Draft-Quality | Do |
| Q3A(R)-Impurities in New Drug Substances-Draft | July 20, 2000 | Do | Do |
| Q3B(R)-Impurities in New Drug Products-Draft | July 19, 2000 | Do | Do |
| Q6A-Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances-Draft | November 25, 1997 | Do | Do |
| Q7A-Good Manufacturing Practice for Active Pharmaceutical Ingredients-Draft | August 1, 2000 | Do | Do |
| S7-Safety Pharmacology Studies for Human Pharmaceuticals-Draft | August 7, 2000 | ICH Draft-Safety | Do |
| E12 A-Principles for Clinical Evaluation of New Antihypertensive Drugs-Draft | August 9, 2000 | ICH Draft-Efficacy | Do |
| M4-Common Technical Document-Draft | August 24, 2000 | ICH Draft-Joint Safety/Efficacy (Multidisciplinary) | Do |
| Q1A-Stability Testing of New Drug Substances and Products | September 22, 1994 | ICH-Quality | Do |
| QIB-Photostability Testing of New Drug Substances and Products | May 16, 1997 | Do | Do |
| QIC-Stability Testing for New Dosage Forms | May 9, 1997 | Do | Do |
| Q2A-Text on Validation of Analytical Procedures | March 1, 1995 | Do | Do |
| Q2B-Validation of Analytical Procedures: Methodology | May 19, 1997 | Do | Do |
| Q3A-Impurities in New Drug Substances | January 4, 1996 | Do | Do |
| Q3B(R)- Impurities in New Drug Products | July 19, 2000 | Do | Do |
| Q3C-Impurities: Residual Solvents | December 24, 1997 | Do | Do |
| Q5A-Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin | September 24, 1998 | Do | Do |
| Q5B-Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products | February 23, 1996 | Do | Do |
| Q5C-Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological Products | July 10, 1996 | Do | Do |
| Q5D-Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products | September 21, 1998 | Do | Do |
| Q6A-Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances | December 29, 2000 | Do | Do |
| Q6B-Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | August 18, 1999 | Do | Do |
| S1A-The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals | March 1, 1996 | ICH-Safety | Do |
| S1B-Testing for Carcinogenicity in Pharmaceuticals | February 23, 1998 | Do | Do |
| S1C-Dose Selection for Carcinogenicity Studies of Pharmaceuticals | March 1, 1995 | Do | Do |
| S1C(R)-Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes | December 4, 1997 | Do | Do |
| S2A-Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals | April 24, 1996 | Do | Do |
| S2B-Genotoxicity: Standard Battery Testing | November 21, 1997 | Do | Do |
| S3A-Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies | March 1, 1995 | Do | Do |
| S3B-Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies | March 1, 1995 | Do | Do |
| S4A-Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) | June 25, 1999 | Do | Do |
| S5A-Detection of Toxicity to Reproduction for Medicinal Products | September 22, 1994 | Do | Do |
| S5B-Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility | April 5, 1996 | Do | Do |
| S6-Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals | November 18, 1997 | Do | Do |
| S7A-Safety Pharmacology Studies for Human Pharmaceuticals | July 13, 2001 | Do | Do |
| EIA-The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions | March 1, 1995 | ICH-Efficacy | Do |
| E2A-Clinical Safety Data Management: Definitions and Standards for Expedited Reporting | March 1, 1995 | Do | Do |
| E2B-Data Elements for Transmission of Individual Case Safety Reports | January 15, 1998 | Do | Do |
| E2C-Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs | May 19, 1997 | Do | Do |
| E3-Structure and Content of Clinical Study Reports | July 17, 1996 | Do | Do |
| E4-Dose-Response Information to Support Drug Registration | November 9, 1994 | Do | Do |
| E5-Ethnic Factors in the Acceptability of Foreign Clinical Data | June 10, 1998 | Do | Do |
| E6-Good Clinical Practice: Consolidated Guideline | May 9, 1997 | Do | Do |
| E7-Studies in Support of Special Populations: Geriatrics | August 2, 1994 | Do | Do |
| E8-General Considerations for Clinical Trials | December 24, 1997 | Do | Do |
| E9-Statistical Principles for Clinical Trials | September 16, 1998 | Do | Do |
| E10-International Conference on Harmonisation: Choice of Control Group and Related Issues in Clinical Trials | May 14, 2001 | Do | Do |
| E11-Clinical Investigation of Medicinal Products in the Pediatric Population | December 15, 2000 | Do | Do |
| M3-Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals | November 25, 1997 | ICH-Joint Safety/Efficacy (Multidisciplinary) | Do |
| A Revision in Sample Collection Under the Compliance Program Pertaining to Pre-Approval Inspections | July 15, 1996 | Industry Letters | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Certification Requirements for Debarred Individuals in Drug Applications | June 1, 1990 | Do | Do |
| Continuation of a Series of Letters Communicating Interim and Informal Generic Drug Policy and Guidance. Availability of Policy and Procedure Guides, and Further Operational Changes to the Generic Drug Review Program | March 2, 1998 | Do | Http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Fifth of a Series of Letters Providing Informal Notice About the Act, Discussing the Statutory Mechanism by Which ANDA Applicants May Make Modifications in Approved Drugs Where Clinical Data Is Required | April 10, 1987 | Do | Do |
| Fourth of a Series of Letters Providing Informal Notice to Affected Parties About Policy Developments and Interpretations Regarding the Act. Three-Year Exclusivity Provisions of Title 1 | October 31, 1986 | Do | Do |
| Implementation of the Drug Price Competition and Patent Term Restoration Act; Preliminary Guidance | October 11, 1984 | Do | Do |
| Implementation Plan USP Injection Nomenclature | October 2, 1995 | Do | Do |
| Instructions for Filing Supplements Under the Provisions of SUPAC-IR | April 11, 1996 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Seventh of a Series of Letters About the Act Providing Guidance on the "180-Day Exclusivity" Provision of Section 505(j)(4)(B)(iv) of the Act | July 29, 1988 | Do | Http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Sixth of a Series of Informal Notice Letters About the Act Discussing 3- and 5-year Exclusivity Provisions of Section 505(c)(3)(D) and (j)(4)(D) of the Act | April 28, 1988 | Do | Do |
| Streamlining Initiative | December 24, 1996 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Supplement to 10/11/84 Letter About Policies, Procedures and Implementation of the Act (Q A Format) | November 16, 1984 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Third of a Series of Letters Regarding the Implementation of the Act | May 1, 1985 | Do | Do |
| Y2K Letter From Dr. Janet Woodcock | October 19, 1998 | Do | Do |
| Combined Oral Contraceptives-Labeling for Healthcare Providers and Patients-Draft | July 10, 2000 | Labeling Draft | Do |
| Content and Format for Geriatric Labeling-Draft | January 21, 1999 | Do | Do |
| Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics-Draft | June 21, 2000 | Do | Do |
| Non-Contraceptive Estrogen Drug Products-Physician and Patient Labeling-Draft | January 8, 1999 | Do | Do |
| Noncontraceptive Estrogen Class Labeling-Draft | September 27, 1999 | Do | Do |
| Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)-Draft | July 16, 1998 | Do | Do |
| Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications-Draft | October 26, 2000 | Do | Do |
| Therapeutic Equivalence Code Placement on Prescription Drug Labels and Labeling-Draft | January 28, 1999 | Do | Do |
| Acetaminophen and Codeine Phosphate Tablets/Capsules | December 1, 1993 | Labeling | Do |
| Acetaminophen and Codeine Phosphate Oral Solution/Suspension | December 1, 1993 | Do | Do |
| Acetaminophen, Aspirin and Codeine Phosphate Tablets/Capsules | December 1, 1993 | Do | Do |
| Alprazolam Tablets USP | August 1, 1996 | Do | Do |
| Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP | September 1, 1997 | Do | Do |
| Amlodipine Besylate Tablets | September 1, 1997 | Do | Do |
| Astemizole Tablets | September 1, 1997 | Do | Do |
| Atenolol Tablets USP | August 1, 1997 | Do | Do |
| Barbiturate, Single Entity-Class Labeling | March 1, 1981 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Butalbital, Acetaminophen and Caffeine Capsules/Tablets USP | September 1, 1997 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Butalbital, Acetaminophen, Caffeine and Hydocodone Bitartrate Tablets | September 21, 1997 | Do | Do |
| Butorphanol Tartrate Injection USP | October 1, 1992 | Do | Do |
| Captopril and Hydrochlorothiazide Tablets USP | April 1, 1995 | Do | Do |
| Captopril Tablets | February 1, 1995 | Do | Do |
| Carbidopa and Levodopa Tablets USP | February 1, 1992 | Do | Do |
| Chlordiazepoxide Hydrochloride Capsules | January 1, 1988 | Do | Do |
| Cimetidine Hydrochloride Injection | September 1, 1995 | Do | Do |
| Cimetidine Tablets | September 1, 1995 | Do | Do |
| Cisapride Oral Suspension | September 1, 1997 | Do | Do |
| Cisapride Tablets | September 1, 1997 | Do | Do |
| Clindamycin Phosphate Injection USP | September 1, 1998 | Do | Do |
| Clorazepate Dipotassium Capsules/Tablets | March 1, 1993 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Combination Oral Contraceptives-Physician and Patient Labeling | January 1, 1994 | Do | Do |
| Cyproheptadine Hydrochloride Tablets/Syrup | December 1, 1986 | Do | Do |
| Diclofenac Sodium Delayed-Release Tablets | January 1, 1997 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Diltiazem Hydrochloride Extended-Release Capsules | September 1, 1995 | Do | Do |
| Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP | April 1, 1995 | Do | Do |
| Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP | April 1, 1995 | Do | Do |
| Dipivefrin Hydrochloride Ophthalmic Solution, 0.1% | November 2, 1998 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Ergoloid Mesylates Tablets | January 1, 1988 | Do | Do |
| Fludeoxyglucose F18 Injection | January 1, 1997 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Flurbiprofen Tablets USP | January 1, 1994 | Do | Do |
| Fluvoxamine Maleate Tablets | September 1, 1997 | Do | Do |
| Gentamicin Sulfate Ophthalmic Ointment and Solution USP | April 1, 1992 | Do | Do |
| Heparin Sodium Injection USP | March 1, 1991 | Do | Do |
| Hydrocodone Bitartrate and Acetaminophen Tablets USP | April 1, 1994 | Do | Do |
| Hydroxyzine Hydrochloride Injection | December 1, 1989 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Hypoglycemic Oral Agents Federal Register | April 1, 1984 | Do | Do |
| Indomethacin Capsules USP | September 1, 1995 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Informal Labeling Guidance Texts for Estrogen Drug Products Patient Labeling | August 1, 1992 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Informal Labeling Guidance Texts for Estrogen Drug Products: Professional Labeling | August 1, 1992 | Do | Do |
| Isoetharine Inhalation Solution | March 1, 1989 | Do | Do |
| Itraconazole Capsules, USP | September 1, 1998 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Leucovorin Calcium for Injection | July 1, 1996 | Do | Do |
| Leucovorin Calcium Tablets, USP | July 1, 1996 | Do | Do |
| Local Anesthetics Class Labeling | September 1, 1982 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Meclofenamate Sodium Capsules | July 1, 1992 | Do | Do |
| Medroxyprogesterone Acetate Tablets, USP | September 1, 1998 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Metaproterenol Sulfate Inhalation Solution USP | May 1, 1992 | Do | Do |
| Metaproterenol Sulfate Syrup USP | May 1, 1992 | Do | Do |
| Metaproterenol Sulfate Tablets | May 1, 1992 | Do | Do |
| Metoclopramide Tablets USP/Oral Solution | February 1, 1995 | Do | Do |
| Naphazoline Hydrochloride Ophthalmic Solution | March 1, 1989 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Naproxen Sodium Tablets, USP | September 1, 1997 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Naproxen Tablets, USP | September 1, 1997 | Do | Do |
| Niacin Tablets | July 1, 1982 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Paclitaxel Injection | September 1, 1997 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Phendimetrazine Tartrate Capsules/T Nets, and Extended-Release Capsules | February 1, 1991 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Phentermine Hydrochloride Capsules/Tablets | August 1, 1988 | Do | Do |
| Promethazine Hydrochloride Tablets | March 1, 1990 | Do | Do |
| Propantheline Bromide Tablets | August 1, 1988 | Do | Do |
| Pyridoxine Hydrochloride Injection | June 1, 1984 | Do | Do |
| Quinidine Sulfate Tablets/Capsules USP | October 1, 1995 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Ranitidine Tablets USP | November 1, 1993 | Do | Do |
| Risperidone Oral Solution | September 1, 1997 | Do | Do |
| Risperidone Tablets | September 1, 1997 | Do | Do |
| Sulfacetainide Sodium and Prednisolone Acetate Ophthalmic Suspension and Ointment | January 1, 1995 | Do | Do |
| Sulfacetamide Sodium Ophthalmic Solution/Ointment | August 1, 1992 | Do | Do |
| Sulfamethoxazole and Phenazopyridine Hydrochloride Tablets | February 1, 1992 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Sulfamethoxazole and Trimethoprim Tablets and Oral Suspension | August 1, 1993 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Theophylline Immediate-Release Dosage Forms | February 1, 1995 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Theophylline Intravenous Dosage Forms | September 1, 1995 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Thiamine Hydrochloride Injection | February 1, 1988 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Tobramycin Sulfate Injection USP | May 1, 1993 | Do | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| Venlafaxine Hydrochloride Tablets | October 1, 1997 | Do | Do |
| Verapamil Hydrochloride Tablets | October 1, 1991 | Do | Do |
| Vitamin A Capsules | February 1, 1992 | Do | Do |
| Zolpidem Tartrate Tablets | September 1, 1997 | Do | Do |
| Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products | April 1, 1996 | Microbiology | Do |
| Labeling OTC Human Drug Products-Submitting Requests for Exemptions and Deferrals-Draft | December 19, 2000 | OTC Draft | Do |
| Labeling OTC Human Drug Products: Updating Labeling in ANDAs-Draft | February 22, 2001 | Do | Do |
| OTC Actual Use Studies-Draft | July 22, 1994 | Do | Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 |
| OTC Nicotine Substitutes-Draft | March 1, 1994 | Do | Do |
| Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) | OTC | http://www.fda.gov/cder/guidance/index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573 | |
| General Guidelines for OTC Combination Products | Do | Do | |
| Labeling OCT Human Drug Products Using a Column Format | December 19, 2000 | Do | Do |
| Upgrading Category III Antiperspirants to Category 1 (43 FR 46728-46731) | Do | Do | |
| Carcinogenicity Study Protocol Submissions-Draft | November 7, 2000 | Pharmacology/Toxicology Draft | Do |
| Immunotoxicology Evaluation of Investigational New Drugs-Draft | May 11, 2001 | Do | Do |
| Photosafety Testing-Draft | January 10, 2000 | Do | Do |
| Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals-Draft | May 8, 2001 | Do | Do |
| Content and Format of INDs for Phase 1 Studies of Drugs Including Well-Characterized, Therapeutic, Biotechnology-Derived Products | October 4, 2000 | Pharmacology/Toxicology | Do |
| Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application | February 1, 1987 | Do | Do |
| Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives | October 16, 1996 | Do | Do |
| Reference Guide for the Nonclinical Toxicity Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies | February 1, 1989 | Do | Do |
| Single Dose Acute Toxicity Testing Toxicity Testing for Pharmaceuticals | August 26, 1996 | Do | Do |
| Applications Covered by Section 505(b)(2)-Draft | December 8, 1999 | Procedural Draft | Do |
| Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products-Draft | March 10, 2000 | Do | Do |
| Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning January 1, 2000-Draft | December 22, 1999 | Do | Do |
| Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution-Draft | May 15, 2001 | Do | Do |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank-Draft | March 29, 2000 | Do | Do |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan-Draft | July 9, 2001 | Do | Do |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act-Draft | August 17, 1999 | Do | Do |
| PET Drug Applications-Content and Format for NDAs and ANDAs-Draft | March 10, 2000 | Do | Do |
| Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines-Draft | March 12, 2001 | Do | Do |
| Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies-Draft | January 4, 2001 | Do | Do |
| Reports on the Status of Postmarketing Studies-Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997-Draft | April 4, 2001 | Do | Do |
| Special Protocol Assessment-Draft | February 9, 2000 | Do | Do |
| Submitting Debarment Certification Statements-Draft | October 2, 1998 | Do | Do |
| 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act | July 14, 1998 | Procedural | Do |
| Advisory Committees: Implementing Section 120 of the Food and Drug Modernization Act of 1997 | November 2, 1998 | Do | Do |
| Court Decisions, ANDA Approvals, and 130-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act | March 30, 2000 | Do | Do |
| Disclosure of Materials Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 | November 30, 1999 | Do | Do |
| Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act | November 23, 1998 | Do | Do |
| Fast Track Drug Development Programs: Designation, Development, and Application Review | November 18, 1998 | Do | Do |
| Financial Disclosure by Clinical Investigators | March 20, 2001 | Do | Do |
| Formal Dispute Resolution: Appeals Above the Division Level | March 7, 2000 | Do | Do |
| Formal Meetings With Sponsors and Applicants for PDUFA Products | March 7, 2000 | Do | Do |
| Implementation of Section 120 of the FDA Modernization Act of 1997-Advisory Committees | November 20, 1998 | Do | Do |
| Implementation of Section 126 of the FDA Modernization Act of 1997-Elimination of Certain Labeling Requirements | July 21, 1998 | Do | Do |
| Levothyroxine Sodium Products-Enforcement of August 14, 2001, Compliance Date and Submission of New Applications | July 13, 2001 | Do | Do |
| National Uniformity for Nonprescription Drugs Ingredient Labeling for OTC Drugs | April 9, 1998 | Do | Do |
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act-Revised | October 1, 1999 | Do | Do |
| Reduction of Civil Money Penalties for Small Business Entities | March 20, 2001 | Do | Do |
| Refusal to File | July 12, 1993 | Do | Do |
| Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act | June 15, 1998 | Do | Do |
| Standards for the Prompt Review of Efficacy Supplements Including Priority Efficacy Supplements | May 15, 1998 | Do | Do |
| Women and Minorities Guidance Requirements | July 20, 1998 | Do | Do |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act | August 17, 1999 | User Fee Draft | Do |
| Submitting Separate Marketing Applications and Definitions of Clinical Data for Purposes of Assessing User Fees-Draft | February 22, 2001 | Do | Do |
| Waivers of and Reductions in User Fees (Attachment G)-Draft | July 16, 1993 | Do | Do |
| Applicability of User Fees to: (1) Applications Withdrawn Before Filing Decision, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest (Attachment F) | July 12, 1993 | User Fee | Do |
| Application, Product, and Establishment Fees: Common Issues and Their Resolution (Attachment D) | December 16, 1994 | Do | Do |
| Classifying Resubmissions in Response to Action Letters | May 14, 1998 | Do | Do |
| Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act | August 25, 1999 | Do | Do |
| Formal Meetings With Sponsors and Applicants for PDUFA Products | March 7, 2000 | Do | Do |
| Submitting and Reviewing Complete Responses to Clinical Holds (Revised) | October 26, 2000 | Do | Do |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | Date of Withdrawal |
|---|---|---|---|
| Dissemination and Reprints of Certain Published Original Data (No Replacement) | October 8, 1996 | Advertising | February 16, 2000 |
| Funded Dissemination of Reference Texts (No Replacement) | October 8, 1996 | Advertising | February 16, 2000 |
| Buspirone Hydrochloride Tablets In Vivo Bioequivalence (No Replacement) | May 14, 1998 | Biopharmaceutics | November 30, 2000 |
| Cimetidine Tablets In Vivo Bioequivalence and In Vitro Dissolution (No Replacement) | Unknown | Biopharmaceutics | November 30, 2000 |
| Diclofenac Sodium (Tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing (No Replacement) | October 6, 1994 | Biopharmaceutics | November 30, 2000 |
| Glipizide In Vivo Bioequivalence and In Vivo Dissolution Testing (No Replacement) | Unknown | Biopharmaceutics | November 30, 2000 |
| Glyburide In Vivo Bioequivalence and In Vivo Dissolution Testing (No Replacement) | Unknown | Biopharmaceutics | November 30, 2000 |
| Oral Extended (Controlled) Release Dosage Forms In Vivo Bioequivalence and In Vitro Dissolution Testing (No Replacement) | Unknown | Biopharmaceutics | November 30, 2000 |
| Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design (No Replacement) | July 1, 1992 | Biopharmaceutics | November 30, 2000 |
| Clinical Evaluation of Drugs to Prevent Dental Caries (No Replacement) | November 1, 1978 | Clinical Medical | May 18, 2000 |
| Clinical Evaluation of Drugs to Prevent, Control, and/or Treat Periodontal Disease (No Replacement) | November 1, 1978 | Clinical Medical | May 18, 2000 |
| OTC Treatment of Hypercholesterolemia (No Replacement) | October 27, 1997 | OTC | August 3, 2000 |
| Levothyroxine Sodium: Questions and Answers (Replaced by Levothyroxine Sodium Products Enforcement of August 14, 2001, Compliance Date and Submission of New Applications issued on July 13, 2001) | March 8, 2001 | Procedural | July 13, 2001 |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet) | FOD No. |
|---|---|---|---|---|
| The FDA Export Reform and Enhancement Act of 1996/Export Certification Package Including "Instructions for Requests for Certificate to Foreign Governments" | February 7, 2000 | Office of Compliance (OC) | Division of Small Manufacturers Assistance; 1-800-638-2041 or 301-827-0111 or (FAX) Facts-on-Demand (FOD) at 1-800-899-0381 or Internet at http://www.fda.gov/ cdrh/ggpmain.html | 865 |
| Commercial Distribution/Exhibit Letter | April 10, 1992 | OC | Do | 246 |
| Color Additive Status List (Inspection Operations Manual) | February 1, 1989 | OC | Do | 268 |
| FDA Guide for Validation of Biological Indicator Incubation Time | January 1, 1986 | OC | Do | 283 |
| Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264) | March 1, 1988 | OC | Do | 286 |
| Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) | September 1, 1989 | OC | Do | 295 |
| Color Additive Petitions (p. 11-19 of PMA Manual) | June 1, 1987 | OC | Do | 296 |
| Guidance for Preparation of PMA Manufacturing Information | August 1, 1992 | OC | Do | 448 |
| Civil Money Penalty Policy; Guidance for FDA Staff | June 8, 1999 | OC | Do | 1124 |
| General Principles of Software Validation; Draft Guidance | June 9, 1997 | OC | Do | 938 |
| Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub. No. 95-4246) | March 1, 1995 | OC | Do | 10 |
| Cover Letter/Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cable | March 9, 1998 | OC | Do | 1197 |
| Guidance on Medical Device Tracking [FDAMA]; Guidance for Industry and FDA Staff | January 24, 2000 | OC | Do | 169 |
| Compliance Program Guidance Manual: Inspection of Medical Devices; Draft | August 12, 1999 | OC | Do | 1702 |
| Procedures for Laboratory Compliance Testing of Television Receivers-Part of TV Packet | May 1, 1986 | OC | Do | 945 |
| Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [510(k)] [CPG 7124.19] | September 24, 1987 | OC | Do | 181 |
| Letter to Medical Device Manufacturer on Pentium Processors | February 14, 1995 | OC | Do | 456 |
| Implementation of the Biomaterials Access Assurance Act of 1998 | April 2, 2001 | OC | Do | 1324 |
| Guideline for the Monitoring of Clinical Investigations | January 1, 1988 | OC | Do | 428 |
| Regulating In Vitro Diagnostic Device (IVD) Studies; Guidance for FDA Staff | December 17, 1999 | OC/Division of Bioresearch Monitoring (DBM) | Do | 1132 |
| Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects | March 19, 1999 | OC/DBM | Do | 2229 |
| Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables | November 15, 1999 | OC/Division of Enforcement (DOE) I | Do | 1129 |
| Guidance on Quality System Regulation Information for Various Premarket Submissions; Draft | August 3, 1999 | OC/DOEII | Do | 1140 |
| Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Guidance for Industry-Draft | July 26, 2000 | OC/DOEII | Do | 1141 |
| Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) | October 13, 1993 | OC/DOEI | Do | 116 |
| Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components | January 1, 1982 | OC/DOEI | Do | 257 |
| Exemption From Reporting and Recordkeeping Requirements for Certain Sunlamp Product Manufacturers | September 16, 1981 | OC/DOEI | Do | 343 |
| Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi) | May 17, 1993 | OC/DOEI | Do | 545 |
| Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) | March 1, 1989 | OC/DOEI | Do | 758 |
| CPG 7133.19: Retention of Microwave Oven Test Record/Cover Letter: 08/24, 1981 Retention of Records Required by 21 CFR [Part] 1002 | March 1, 1995 | OC/DOEI | Do | 880 |
| Guideline for the Manufacture of In Vitro Diagnostic Products | January 10, 1994 | OC/DOEI | Do | 918 |
| A Guide for the Submission of Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting Device | March 1, 1996 | OC/DOEI | Do | 977 |
| A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use | March 1, 1996 | OC/DOEI | Do | 978 |
| A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems | March 1, 1996 | OC/DOEI | Do | 979 |
| Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff | March 15, 2000 | OC/DOEI | Do | 1133 |
| Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA | April 2, 2001 | OC/DOEI | Do | 2619 |
| Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10 | April 1, 1971 | OC/DOEIIII | Do | 235 |
| Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)-E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems | August 1, 1995 | OC/DOEIIII | Do | 236 |
| Guide for Preparing Reports on Radiation Safety of Microwave Ovens | March 1, 1985 | OC/DOEIIII | Do | 239 |
| Reporting Guide for Laser Light Shows and Displays (21 CFR [Part] 1002) (FDA 88-8140) | September 1, 1995 | OC/DOEIIII | Do | 251 |
| Guide for Filing Annual Reports for X-Ray Components and Systems | July 1, 1980 | OC/DOEIIII | Do | 253 |
| Reporting and Compliance Guide for Television Products Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance | October 1, 1995 | OC/DOEIIII | Do | 260 |
| Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (Replaces FDA 82-8127) | September 1, 1995 | OC/DOEIIII | Do | 264 |
| Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use | September 1, 1996 | OC/DOEIIII | Do | 399 |
| Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service Manuals | October 31, 1988 | OC/DOEIIII | Do | 697 |
| Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic Products | August 1, 1995 | OC/DOEIIII | Do | 951 |
| Guide for Preparing Product Reports for Medical Ultrasound Products | September 1, 1996 | OC/DOEIIII | Do | 960 |
| Letter-Manufacturers, Distributors and Importers of Condom Products | February 23, 1994 | OC/DOEII | Do | 52 |
| Letter-Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) | February 13, 1989 | OC/DOEII | Do | 53 |
| Letter-Condom Manufacturers and Distributors | April 5, 1994 | OC/DOEII | Do | 56 |
| Letter to Manufacturers/Repackers Using Cotton | April 22, 1994 | OC/DOEII | Do | 101 |
| Guide for Preparing Product Reports for Lasers and Products Containing Lasers | September 1, 1995 | OC/DOEII | Do | 277 |
| Compliance Guide for Laser Products (FDA 86-8260) | September 1, 1985 | OC/DOEII | Do | 278 |
| Condoms: Inspection and Sampling at Domestic Manufacturers and of All Repackers; Sampling From All Importers (Damaska Memo to Field on 4/8, 1987) | April 8, 1987 | OC/DOEII | Do | 293 |
| Dental Handpiece Sterilization (Dear Doctor Letter) | September 28, 1992 | OC/DOEII | Do | 589 |
| Latex Labeling Letter (Johnson) | March 18, 1993 | OC/DOEII | Do | 831 |
| Pesticide Regulation Notice 94-4: Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides With Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA | June 30, 1994 | OC/DOEII | Do | 851 |
| Letter to Industry, Powered Wheelchair Manufacturers From RM Johnson | May 10, 1993 | OC/DOEII | Do | 869 |
| Hazards of Volume Ventilators and Heated Humidifiers | September 15, 1993 | OC/DOEII | Do | 901 |
| Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals | February 3, 1994 | OC/DOEII | Do | 933 |
| Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure | June 23, 1978 | OC/DOEII | Do | 1019 |
| Letter to: Manufacturers and Users of Lasers for Refractive Surgery [Excimer] | October 10, 1996 | OC/DOEII | Do | 1093 |
| Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy | August 23, 1996 | OC/DOEII | Do | 1122 |
| Surveillance and Detention Without Physical Examination of Condoms; Guidance for Industry; Draft | August 14, 2000 | OC/DOEII | Do | 1139 |
| All U.S. Condom Manufacturers, Importers and Repackagers | April 7, 1987 | OC/DOEII | Do | 2510 |
| Manufacturers and Initial Distributors of Hemodialyzers | May 23, 1996 | OC/DOEII | Do | 2507 |
| Laser Light Show Safety-Who's Responsible? (FDA 86-8262) | May 1, 1986 | OC/DOEIII | Do | 13 |
| Suggested State Regulations for Control of Radiation-Volume II Nonionizing Radiation-Lasers (FDA Pub. No. 83-8220) | January 1, 1982 | OC/DOEIII | Do | 70 |
| Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards Exist | May 28, 1981 | OC/DOEIII | Do | 231 |
| Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10 | March 1, 1973 | OC/DOEIII | Do | 237 |
| Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10 | April 30, 1974 | OC/DOEIII | Do | 240 |
| Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | February 1, 1975 | OC/DOEIII | Do | 241 |
| Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) | October 1, 1987 | OC/DOEIII | Do | 243 |
| Computerized Devices/Processes Guidance-Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes | May 1, 1992 | OC/DOEIII | Do | 247 |
| Guide for Preparing Product Reports for Ultrasonic Therapy Products (Physical Therapy Only) | August 1, 1996 | OC/DOEIII | Do | 249 |
| Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137) | September 1, 1980 | OC/DOEIII | Do | 254 |
| Guide for Preparing Annual Reports for Ultrasonic Therapy Products | September 1, 1996 | OC/DOEIII | Do | 261 |
| Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (Replaces FDA 82-8127) | September 1, 1995 | OC/DOEIII | Do | 262 |
| Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (Replaces FDA 82-8127) | September 1, 1995 | OC/DOEIII | Do | 263 |
| Quality Control Guide for Sunlamp Products (FDA 88-8234) | March 1, 1988 | OC/DOEIII | Do | 270 |
| Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems | September 1, 1984 | OC/DOEIII | Do | 271 |
| Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR [Part] 1002) | September 1, 1995 | OC/DOEIII | Do | 279 |
| Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products | August 21, 1986 | OC/DOEIII | Do | 342 |
| Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR [Part] 1002) | September 1, 1995 | OC/DOEIII | Do | 348 |
| Quality Control Practices for Compliance With the Federal Mercury Vapor Lamp Performance Standard | May 1, 1980 | OC/DOEIII | Do | 349 |
| Keeping Up With the Microwave Revolution (FDA Pub. No. 91-4160) | March 1, 1990 | OC/DOEIII | Do | 356 |
| Quality Assurance Guidelines for Hemodialysis Devices | February 1, 1991 | OC/DOEIII | Do | 507 |
| Letter to Manufacturers and Importers of Microwave Ovens-Open Door Operation of Microwave Ovens as a Result of Oven Miswiring | March 28, 1980 | OC/DOEIII | Do | 646 |
| Reporting of New Model Numbers to Existing Model Families | June 14, 1983 | OC/DOEIII | Do | 675 |
| Import: Radiation-Producing Electronic Products (FDA 89-8008) | November 1, 1988 | OC/DOEIII | Do | 756 |
| Unsafe Patient Lead Wires and Cables | September 3, 1993 | OC/DOEIII | Do | 889 |
| Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device [Form FDA 3147] | July 1, 1998 | OC/DOEIII | Do | 903 |
| Letter to Trade Association: Reuse of Single-Use or Disposable Medical Devices | December 27, 1995 | OC/DOEIII | Do | 961 |
| Design Control Guidance for Medical Device Manufacturers | March 11, 1997 | OC/DOEIII | Do | 994 |
| Keeping Medical Devices Safe From Electromagnetic Interference | July 1, 1995 | OC/DOEIII | Do | 1081 |
| Medical Devices and EMI: The FDA Perspective | January 1, 1995 | OC/DOEIII | Do | 1082 |
| Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations | OC/DOEIII | Do | 1086 | |
| Safety of Electrically Powered Products: Letter to Medical Device and Electronic Product Manufacturers From Lillian Gill and BHB Correction Memo | September 18, 1996 | OC/DOEIII | Do | 1087 |
| Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff | August 14, 2000 | OC/DOEIII | Do | 1168 |
| Labeling for Electronic Anti-Theft Systems; Guidance for Industry; Final | August 15, 2000 | OC/DOEIII | Do | 1170 |
| Wireless Medical Telemetry Risks and Recommendations, Guidance for Industry; Final | September 27, 2000 | OC/DOEIII | Do | 1173 |
| Policy on Warning Label Required on Sunlamp Products | June 25, 1985 | OC/DOEIII | Do | 1343 |
| Policy on Lamp Compatibility (Sunlamps) | September 2, 1986 | OC/DOEIII | Do | 2343 |
| Guidance for Industry on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval | August 5, 1999 | OC/Division of Program Operations (DPO) | Do | 1269 |
| Guidance on IDE Policies and Procedures [FDAMA]; Final | January 20, 1998 | Office of Device Evaluation (ODE) | Do | 882 |
| Color Additives for Medical Devices | November 15, 1995 | ODE | Do | 575 |
| Preamendment Class III Devices | March 11, 1992 | ODE | Do | 584 |
| Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size Distribution | Date not available | ODE | Do | 595 |
| Guidance for Submitting Reclassification Petition | June 1, 1989 | ODE | Do | 609 |
| Electromagnetic Compatibility for Medical Devices: Issues and Solutions; Memorandum | June 13, 1995 | ODE | Do | 639 |
| SMDA Changes-Premarket Notification; Regulatory Requirements for Medical Devices [510(k)] Manual Insert | April 17, 1992 | ODE | Do | 655 |
| "Real-Time" Review Program for Premarket Approval Application (PMA) Supplements | April 22, 1997 | ODE | Do | 673 |
| Classified Convenience Kits | April 30, 1993 | ODE | Do | 789 |
| 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; Final | February 19, 1998 | ODE | Do | 795 |
| Suggested Content for Original IDE Application Cover Letter-Version 4 | February 27, 1996 | ODE | Do | 797 |
| Device Specific Guidance Documents (List) | May 11, 1993 | ODE | Do | 815 |
| PMA Shell Development and Modular Review; Guidances for the Medical Device Industry; Final | November 6, 1998 | ODE | Do | 835 |
| Determination of Intended Use for 510(k) Devices-Guidance for Industry and CDRH Staff [FDAMA]; Final | January 30, 1998 | ODE | Do | 857 |
| Premarket Notification [510(k)] Status Request Form, Revised | March 14, 1997 | ODE | Do | 858 |
| CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File Policies | June 30, 1993 | ODE | Do | 859 |
| Indications for Use Statement | February 6, 1996 | ODE | Do | 879 |
| The New 510(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Final | March 20, 1998 | ODE | Do | 905 |
| Preamendments Class III Strategy; SXAlpert | April 19, 1994 | ODE | Do | 611 |
| Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer From Susan Alpert, Ph.D., M.D. | May 26, 1994 | ODE | Do | 883 |
| ODE Executive Secretary Guidance Manual | August 7, 1987 | ODE | Do | 1338 |
| Modifications to Devices Subject to Premarket Approval-The PMA Supplement Decision Making Process; Guidance for Industry; Draft | August 6, 1998 | ODE | Do | 102 |
| CDRH Submissions Coversheet [PMA/PDP/510k/IDE] | May 8, 1998 | ODE | Do | 147 |
| Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff [FDAMA]; Final | February 19, 1998 | ODE | Do | 159 |
| Limulus Amebocyte Lysate; Reduction of Samples for Testing | October 23, 1987 | ODE | Do | 178 |
| Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance | April 1, 1996 | ODE | Do | 198 |
| New Section 513(f)(2)-Evaluation of Automatic Class III Designation; Guidance for Industry and CDRH Staff [FDAMA]; Final | February 19, 1998 | ODE | Do | 199 |
| Methods for Conducting Recall Effectiveness Checks | June 16, 1978 | ODE | Do | 225 |
| Suggestions for Submitting a Premarket Approval (PMA) Application | April 1, 1993 | ODE | Do | 228 |
| Guidance for Off-the-Shelf Software Use in Medical Devices; Final | September 9, 1999 | ODE | Do | 1252 |
| Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices | December 1, 1983 | ODE | Do | 267 |
| Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products (From John C. Petricciani, M.D.) | June 1, 1984 | ODE | Do | 269 |
| Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA] | February 19, 1998 | ODE | Do | 310 |
| Format for IDE Progress Reports | June 1, 1996 | ODE | Do | 311 |
| Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies-For Use by CDRH and Industry [FDAMA]; Final | February 19, 1998 | ODE | Do | 322 |
| Industry Representatives on Scientific Panels | March 27, 1987 | ODE | Do | 329 |
| PMA Review Schedule [P87-1] | March 31, 1988 | ODE | Do | 333 |
| Necessary Information for Diagnostic Ultrasound 510(k) (Draft) | November 24, 1987 | ODE | Do | 335 |
| Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; Final | May 29, 1998 | ODE | Do | 337 |
| Master Files Part III; Guidance on Scientific and Technical Information | June 1, 1987 | ODE | Do | 338 |
| 510(k) Quality Review Program (Blue Book Memo) (I96-1) | March 29, 1996 | ODE | Do | 344 |
| FDA Policy for the Regulation of Computer Products (Draft) | November 13, 1989 | ODE | Do | 351 |
| Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 | January 1, 1990 | ODE | Do | 352 |
| 4-of-A-Kind PMAs | October 1, 1991 | ODE | Do | 371 |
| Supplements to Approved Applications for Class III Medical Devices: Use Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; Final | May 20, 1998 | ODE | Do | 380 |
| Substantial Equivalence (SE) Decision Making Documentation ATTACHED: "SE" Decision Making Process (Detailed), i.e., the Decision Making Tree | January 1, 1990 | ODE | Do | 390 |
| Shelf Life of Medical Devices | March 1, 1991 | ODE | Do | 415 |
| Guideline on General Principles of Process Validation | May 1, 1987 | ODE | Do | 425 |
| Guideline on Sterile Drug Products Produced by Aseptic Processing | June 1, 1987 | ODE | Do | 426 |
| Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test | December 1, 1987 | ODE | Do | 427 |
| General/Specific Intended Use [FDAMA]; Draft Guidance for Industry | November 4, 1998 | ODE | Do | 499 |
| Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo # P98-1]; Final | October 10, 1997 | ODE | Do | 563 |
| Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated 6/25, 1993, Device "Fast Track" Plan Announcement (Include with 926-930) | June 30, 1993 | ODE | Do | 931 |
| New Model Medical Device Development Process; Guidance for Industry; Final | July 21, 1998 | ODE | Do | 1101 |
| Guidance on the Use of Standards in Substantial Equivalence Determinations; Final | March 12, 2000 | ODE | Do | 1131 |
| Guidance for Industry and for FDA Reviewers; Interpretive Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 | August 9, 2000 | ODE | Do | 1135 |
| Evidence Models for the Least Burdensome Means to Market; Guidance for Industry and FDA Reviewers; Draft | September 1, 1999 | ODE | Do | 1154 |
| Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities | September 3, 1996 | ODE | Do | 1198 |
| Deciding When to Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry | November 30, 2000 | ODE | Do | 1073 |
| Guidance on Amended Procedures for Advisory Panel Meetings | July 22, 2000 | ODE | Do | 413 |
| Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final | November 16, 1998 | ODE | Do | 2206 |
| Frequently Asked Questions on the New 510(k) Paradigm; Guidance for Industry; Final | October 22, 1998 | ODE | Do | 2230 |
| The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Draft Guidance for FDA and Industry | May 3, 2001 | ODE | Do | 1332 |
| Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters | September 12, 1994 | ODE Division of Reproductive, Abdominal, and Radiological Devices (DRARD) | Do | 97 |
| Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastroenterology and Urology | November 1, 1994 | ODE/DRARD | Do | 98 |
| Convenience Kits Interim Regulatory Guidance (Include 874) | May 20, 1997 | ODE/510K | Do | 562 |
| Announcement: Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Categorization of Investigational Devices # D95-2 (Blue Book Memo) | September 15, 1995 | ODE/BlueBook | Do | 106 |
| Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices # G90-2 (Blue Book Memo) | October 19, 1990 | ODE/BlueBook | Do | 30 |
| Consolidated Review of Submissions for Lasers and Accessories # G90-1 (Blue Book Memo) | October 19, 1990 | ODE/BlueBook | Do | 31 |
| Review of Final Draft Medical Device Labeling # P91-4 (Blue Book Memo) | August 29, 1991 | ODE/BlueBook | Do | 34 |
| Review of 510(k)s for Computer Controlled Medical Devices # K91-1 (Blue Book Memo) | August 29, 1991 | ODE/BlueBook | Do | 35 |
| Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (Replaces # G87-1 # 8294) (Blue Book Memo) | May 1, 1995 | ODE/BlueBook | Do | 164 |
| ODE Regulatory Information for the Office of Compliance-Information Sharing Procedures # G87-2 (Blue Book Memo) | May 15, 1987 | ODE/BlueBook | Do | 276 |
| Panel Review of "Me-Too" Devices # P86-6 (Blue Book Memo) | July 1, 1986 | ODE/BlueBook | Do | 280 |
| Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program # K86-3 (Blue Book Memo) | June 30, 1986 | ODE/BlueBook | Do | 289 |
| PMA Filing Decisions # P90-2 (Blue Book Memo) | May 18, 1990 | ODE/BlueBook | Do | 297 |
| PMAs-Early Review and Preparation of Summaries of Safety and Effectiveness # P86-1 (Blue Book Memo) | January 27, 1986 | ODE/BlueBook | Do | 302 |
| Criteria for Panel Review of PMA Supplements # P86-3 (Blue Book Memo) | January 30, 1986 | ODE/BlueBook | Do | 304 |
| Review and Approval of PMAs of Licensees # P86-4 (Blue Book Memo) | October 22, 1990 | ODE/BlueBook | Do | 305 |
| Panel Report and Recommendations on PMA Approvals # P86-5 (Blue Book Memo) | April 18, 1986 | ODE/BlueBook | Do | 306 |
| 510(k) Sign-Off Procedures # K94-2 (Blue Book Memo) | June 3, 1994 | ODE/BlueBook | Do | 308 |
| Review of Laser Submissions # G88-1 (Blue Book Memo) | April 15, 1988 | ODE/BlueBook | Do | 330 |
| Delegation of IDE Actions # D88-1 (Blue Book Memo) | April 26, 1988 | ODE/BlueBook | Do | 331 |
| Premarket Notification-Consistency of Reviews # K89-1 (Blue Book Memo) | February 28, 1989 | ODE/BlueBook | Do | 339 |
| Telephone Communications Between ODE Staff and Manufacturers # I93-1 (Blue Book Memo) | January 29, 1993 | ODE/BlueBook | Do | 360 |
| 510(k) Sterility Review Guidance-and Revision of 11/18/1994 # K90-1 (Blue Book Memo) | February 12, 1990 | ODE/BlueBook | Do | 361 |
| Review of IDEs for Feasibility Studies # D89-1 (Blue Book Memo) | May 17, 1989 | ODE/BlueBook | Do | 362 |
| Toxicology Risk Assessment Committee # G89-1 (Blue Book Memo) | August 9, 1989 | ODE/BlueBook | Do | 363 |
| Assignment of Review Documents # I90-2 (Blue Book Memo) | August 24, 1990 | ODE/BlueBook | Do | 366 |
| Meetings With the Regulated Industry # I89-3 (Blue Book Memo) | November 20, 1989 | ODE/BlueBook | Do | 367 |
| Policy Development and Review Procedures # I90-1 (Blue Book Memo) | February 15, 1990 | ODE/BlueBook | Do | 368 |
| PMA Supplements: ODE Letter to Manufacturers; Identifies Situations Which May Require the Submission of a PMA Supplement (When PMA Supplements Are Required) # P90-1 (Blue Book Memo) | April 24, 1990 | ODE/BlueBook | Do | 387 |
| 510(k) Refuse to Accept Procedures # K94-1 (Blue Book Memo) | May 20, 1994 | ODE/BlueBook | Do | 401 |
| PMA Refuse to File Procedures # P94-1 (Blue Book Memo) | May 20, 1994 | ODE/BlueBook | Do | 402 |
| Premarket Approval Application (PMA) Closure # P94-2 (Blue Book Memo) | July 8, 1994 | ODE/BlueBook | Do | 403 |
| PMA/510(k) Triage Review Procedures # G94-1 (Blue Book Memo) | May 20, 1994 | ODE/BlueBook | Do | 404 |
| Goals and Initiatives for the IDE Program # D95-1 (Blue Book Memo) | July 12, 1995 | ODE/BlueBook | Do | 405 |
| Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (Blue Book Memo # K95-1) | November 21, 1995 | ODE/BlueBook | Do | 406 |
| IDE Refuse to Accept Procedures # D94-1 (Blue Book Memo) | May 20, 1994 | ODE/BlueBook | Do | 410 |
| Device Labeling Guidance # G91-1 (Blue Book Memo) | March 8, 1991 | ODE/BlueBook | Do | 414 |
| Clinical Utility and Premarket Approval # P91-1 (Blue Book Memo) | May 3, 1991 | ODE/BlueBook | Do | 443 |
| Panel Review of Premarket Approval Applications # P91-2 (Blue Book Memo) | May 3, 1991 | ODE/BlueBook | Do | 444 |
| PMA Compliance Program # P91-3 (Blue Book Memo) | May 3, 1991 | ODE/BlueBook | Do | 445 |
| Document Review Processing # I91-1 (Blue Book Memo) | February 12, 1992 | ODE/BlueBook | Do | 446 |
| Integrity of Data and Information Submitted to ODE # I91-2 (Blue Book Memo) | May 29, 1991 | ODE/BlueBook | Do | 447 |
| Nondisclosure of Financially Sensitive Information # I92-1 (Blue Book Memo) | March 5, 1992 | ODE/BlueBook | Do | 587 |
| Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo # G96-3)) | August 9, 1996 | ODE/BlueBook | Do | 806 |
| Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) | July 15, 1996 | ODE/BlueBook | Do | 872 |
| 510(k) Additional Information Procedures # K93-1 (Blue Book Memo) | July 23, 1993 | ODE/BlueBook | Do | 886 |
| Overdue IDE Annual Progress Report Procedures # D93-1 (Blue Book Memo) | July 23, 1993 | ODE/BlueBook | Do | 887 |
| Documentation and Resolution of Differences of Opinion on Product Evaluations # G93-1 (Blue Book Memo) | December 23, 1993 | ODE/BlueBook | Do | 920 |
| Deciding When to Submit a 510(k) for a Change to an Exisiting Device; (Blue Book Memo # K97-1) | January 10, 1997 | ODE/BlueBook | Do | 1935 |
| Interagency Agreement Between FDA and HCFA; # D95-2, Attachment A | September 15, 1995 | ODE/BlueBook | Do | 2106 |
| Executive Secretaries Guidance Manual # G87-3 | August 7, 1987 | ODE/BlueBook | Do | 2326 |
| Criteria for Categorization of Investigational Devices (HCFA); # D95-2, Attachment B | September 15, 1995 | ODE/BlueBook | Do | 3106 |
| Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy-(Updated Checklist March 14, 1995) | June 30, 1993 | ODE/BlueBook | Do | 3859 |
| HCFA Reimbursement Categorization Determinations for FDA-Approved IDEs | October 31, 1995 | ODE/BlueBook | Do | 4106 |
| Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy | June 30, 1993 | ODE/BlueBook | Do | 4859 |
| Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; Draft Guidance-Not for Implementation | November 14, 2000 | ODE Division of Clinical Laboratory Devices (DCLD) | Do | 152 |
| Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies | August 31, 1995 | ODE/DCLD | Do | 1191 |
| Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; Draft | December 21, 1999 | ODE/DCLD | Do | 1359 |
| Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA) | February 1, 1994 | ODE/DCLD | Do | 51 |
| Review Criteria for Blood Culture Systems | August 12, 1991 | ODE/DCLD | Do | 82 |
| Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance | September 26, 1994 | ODE/DCLD | Do | 95 |
| Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery | February 20, 1996 | ODE/DCLD | Do | 122 |
| Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies; Draft | August 31, 1995 | ODE/DCLD | Do | 1191 |
| Review Criteria for Assessment of Rheumatoid Factor (RF) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry | February 21, 1997 | ODE/DCLD | Do | 165 |
| Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Points to Consider Regarding Labeling and Premarket Submissions; Draft | October 1, 1988 | ODE/DCLD | Do | 272 |
| Guidance for Submission of Immunohistochemistry Applications to the FDA; Final | June 3, 1998 | ODE/DCLD | Do | 364 |
| Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers | July 15, 1991 | ODE/DCLD | Do | 417 |
| Review Criteria for Assessment of Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies | July 15, 1994 | ODE/DCLD | Do | 459 |
| Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies; Draft | September 26, 1991 | ODE/ | Do | 475 |
| Points to Consider for Hematology Quality Control Materials | September 30, 1997 | ODE/DCLD | Do | 512 |
| Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents | August 1, 1992 | ODE/DCLD | Do | 527 |
| Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March 14, 1996 | February 1, 1996 | ODE/DCLD | Do | 553 |
| Review Criteria for Devices Intended for the Detection of Hepatitis B "e" Antigen and Antibody to HBe | December 30, 1991 | ODE/DCLD | Do | 554 |
| Guidance Criteria for Cyclosporine PMAs | January 24, 1992 | ODE/DCLD | Do | 564 |
| Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter Pylori | September 17, 1992 | ODE/DCLD | Do | 588 |
| Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) | September 27, 1995 | ODE/DCLD | Do | 592 |
| Premarketing Approval Review Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) With Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bi; Draft | September 10, 1992 | ODE/DCLD | Do | 603 |
| Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology | February 14, 1996 | ODE/DCLD | Do | 604 |
| Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home Use | July 14, 1995 | ODE/DCLD | Do | 605 |
| Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases | May 31, 1990 | ODE/DCLD | Do | 629 |
| Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; Draft | September 30, 1991 | ODE/DCLD | Do | 658 |
| Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 | May 15, 1992 | ODE/DCLD | Do | 770 |
| Guidance Document for 510(k) Submission of Fecal Occult Blood Tests; Draft | July 29, 1992 | ODE/DCLD | Do | 772 |
| Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens | January 1, 1992 | ODE/DCLD | Do | 778 |
| Guidance Document for 510(k) Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; Draft | September 1, 1992 | ODE/DCLD | Do | 785 |
| Review Criteria for the Assessment of Allergen-Specific Immunoglobulin E (IGE) In Vitro Diagnostic Devices Using Immunological Test Methodologies | March 2, 1993 | ODE/DCLD | Do | 800 |
| Review Criteria for the Assessment of Anti-Nuclear Antibodies (ANA) In Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA). | September 1, 1992 | ODE/DCLD | Do | 848 |
| Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; Draft | June 14, 1993 | ODE/DCLD | Do | 861 |
| Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] | July 6, 1993 | ODE/DCLD | Do | 862 |
| Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers | June 10, 1996 | ODE/DCLD | Do | 950 |
| Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification [510(k)] to FDA | September 19, 1996 | ODE/DCLD | Do | 957 |
| Points to Consider for Cervical Cytology Devices | July 25, 1994 | ODE/DCLD | Do | 968 |
| Review Criteria for In Vitro Diagnostic Devices That Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) | February 15, 1996 | ODE/DCLD | Do | 980 |
| In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Guidance for Industry; Final | July 6, 1998 | ODE/DCLD | Do | 1102 |
| In Vitro Diagnostic Chloride Test System; Guidance for Industry; Final | July 6, 1998 | ODE/DCLD | Do | 1103 |
| In Vitro Diagnostic Creatinine Test System; Guidance for Industry; Final | July 2, 1998 | ODE/DCLD | Do | 1104 |
| In Vitro Diagnostic Glucose Test System; Guidance for Industry; Final | July 6, 1998 | ODE/DCLD | Do | 1105 |
| In Vitro Diagnostic Potassium Test System; Guidance for Industry; Final | July 6, 1998 | ODE/DCLD | Do | 1107 |
| In Vitro Diagnostic Sodium Test System; Guidance for Industry; Final | July 6, 1998 | ODE/DCLD | Do | 1109 |
| In Vitro Diagnostic Urea Nitrogen Test System; Guidance for Industry; Final | July 6, 1998 | ODE/DCLD | Do | 1110 |
| Guidance for Administrative Procedures for CLIA Categorization; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; Draft | August 14, 2000 | ODE/DCLD | Do | 1143 |
| Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA Applications | March 1, 2001 | ODE/DCLD | Do | 1147 |
| Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)s | July 22, 2000 | ODE/DCLD | Do | 1171 |
| Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s | July 22, 2000 | ODE/DCLD | Do | 1172 |
| Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; Draft | March 8, 2000 | ODE/DCLD | Do | 631 |
| In Vitro Diagnostic C-Reactive Protein Immunological Test System; Guidance for Industry; Final | July 20, 1998 | ODE/DCLD | Do | 1246 |
| Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Guidance for Industry: Final | February 22, 1999 | ODE/DCLD | Do | 1247 |
| Guidance on Labeling for Laboratory Tests; Guidance for Industry; Draft | June 24, 1999 | ODE/DCLD | Do | 1352 |
| Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That Are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Draft | October 8, 1999 | ODE/DCLD | Do | 1353 |
| Class II Special Control Guidance Document for Anti-Saccharomyces Cerevisiae (S. Cerevisiae) Antibody (ASCA) Premarket Notifications; Final | August 23, 2000 | ODE/DCLD | Do | 1183 |
| Guidance for Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final; Guidance for Industry and FDA | November 1, 2000 | ODE/DCLD | Do | 1184 |
| Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs | October 30, 1996 | ODE/DCLD | Do | 1631 |
| Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Guidance for Industry; Draft | November 14, 2000 | ODE/DCLD | Do | 2209 |
| Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Guidance for Industry | February 3, 1999 | ODE/DCLD | Do | 2231 |
| Document for Special Controls for Erythropoietin Assay Premarket Notifications [510(k)s]; Guidance for Industry; Final | April 28, 1999 | ODE/DCLD | Do | 2241 |
| In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Guidance for Industry and FDA Reviewers/Staff; Final | April 27, 1999 | ODE/DCLD | Do | 2242 |
| Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers | November 30, 2000 | ODE/DCLD | Do | 1072 |
| Guidance for Electrical Safety, Electromagnetic Compatibility and Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions | June 28, 2000 | ODE Division of Cardiovascular and Respiratory Devices (DCRD) | Do | 1161 |
| Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final | November 1, 2000 | ODE/DCRD | Do | 372 |
| Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers | November 8, 2000 | ODE/DCRD | Do | 1199 |
| Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final | November 1, 2000 | ODE/DCRD | Do | 1357 |
| Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff | January 31, 2001 | ODE/DCRD | Do | 1358 |
| 1-Consolidated Annual Report for a Device Product Line (1-CARD); Pilot for Preparation of Annual Reports for Pacemaker Premarket Approval Applications | July 6, 2000 | ODE/DCRD | Do | 1167 |
| Excerpts Related to EMI From November 1993 Anesthesiology and Respiratory Devices Branch (Including Electromagnetic Compatibility Standard for Medical Devices; 10/1/79) | November 1, 1993 | ODE/DCRD | Do | 638 |
| Guidance for Infant/Child Apnea Monitor 510(k) Submissions | September 22, 2000 | ODE/DCRD | Do | 1178 |
| Guidance for Industry and for FDA Reviewers: Recommended Clinical Study Design for Ventricular Tachycardia Ablation | May 7, 1999 | ODE/DCRD | Do | 2244 |
| Guidance for Industry: Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Draft | August 25, 1999 | ODE/DCRD | Do | 266 |
| Guidance for Cardiovascular Intravascular Filter 510(k) Submission; Final | November 26, 1999 | ODE/DCRD | Do | 24 |
| Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Electrode-Version 1.0 | February 11, 1997 | ODE/DCRD | Do | 25 |
| Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Lead Switching Adapter-Version 1.0 | February 11, 1997 | ODE/DCRD | Do | 26 |
| Guidance Document Device: Electrocardiograph (ECG) Surface Electrode Tester-Version 1.0 | February 11, 1997 | ODE/DCRD | Do | 27 |
| Draft Guidance Outline-Points to Consider for Clinical Studies for Vasovasostomy Devices | November 30, 1993 | ODE/DCRD | Do | 100 |
| Medical Device Labeling-Suggested Format and Content; Draft Document | April 25, 1997 | ODE/DCRD | Do | 119 |
| Non-Invasive Blood Pressure (NIBP) Monitor Guidance | March 10, 1997 | ODE/DCRD | Do | 123 |
| Policy for Expiration Dating (DCRD RB92-G) | October 30, 1992 | ODE/DCRD | Do | 137 |
| Human Heart Valve Allografts; Draft | June 21, 1991 | ODE/DCRD | Do | 224 |
| Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final | February 16, 2000 | ODE/DCRD | Do | 1632 |
| Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final | February 21, 2000 | ODE/DCRD | Do | 1622 |
| Balloon Valvuloplasty Guidance for the Submission of an IDE Application and a PMA Application | January 1, 1989 | ODE/DCRD | Do | 370 |
| Replacement Heart Valve Guidance; Draft | October 14, 1994 | ODE/DCRD | Do | 375 |
| Implantable Pacemaker Testing Guidance | January 12, 1990 | ODE/DCRD | Do | 383 |
| Letter/Guidance: Vascular Graft Manufacturer, Developer, or Representative | May 11, 1990 | ODE/DCRD | Do | 391 |
| Reviewer Guidance for Ventilators; Draft | July 1, 1995 | ODE/DCRD | Do | 500 |
| Draft 510(k) Checklist for Urological Irrigation System and Tubing Set | August 1, 1995 | ODE/DCRD | Do | 515 |
| Draft Guidance to Firms on Biliary Lithotripsy Studies | August 2, 1990 | ODE/DCRD | Do | 522 |
| Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) | November 11, 1994 | ODE/DCRD | Do | 533 |
| Letter: Notice to Manufacturers of Bone Mineral Densitometers | September 25, 1997 | ODE/DCRD | Do | 552 |
| Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Draft | September 30, 1997 | ODE/DCRD | Do | 560 |
| Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters | January 24, 1992 | ODE/DCRD | Do | 567 |
| Guideline for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age | May 1, 1990 | ODE/DCRD | Do | 577 |
| Guidance for the Preparation of the Annual Report to the PMA Approved Heart Valve Prostheses | April 1, 1990 | ODE/DCRD | Do | 582 |
| Draft Version: Electrode Recording Catheter Preliminary Guidance (Data to Be Sumitted to the FDA in Support of Premarket Notifications [510(k)s]) | March 1, 1995 | ODE/DCRD | Do | 602 |
| Cardiac Ablation Preliminary Guidance (Data to Be Submitted to the FDA in Support Investigation Device Exemption Application; Draft | March 1, 1995 | ODE/DCRD | Do | 619 |
| Premarket Testing Guidelines for Falloposcopes | November 20, 1992 | ODE/DCRD | Do | 621 |
| Guidelines for Evaluation of Non-Drug IUDs | September 28, 1976 | ODE/DCRD | Do | 641 |
| Simplified 510(k) procedures for certain radiology devices: 12/21, 1993, letter from L Yin, ODE/ODE/DRARD, to NEMA | December 21, 1993 | ODE/DCRD | Do | 708 |
| Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology | August 16, 1995 | ODE/DCRD | Do | 768 |
| Heated Humidifier Review Guidance | August 30, 1991 | ODE/DCRD | Do | 780 |
| Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators | October 1, 1993 | ODE/DCRD | Do | 784 |
| Reviewer Guidance for Automatic X-Ray Film Processor 510(k) | February 1, 1990 | ODE/DCRD | Do | 788 |
| Guidance for the Technical Content of a Premarket Approval (PMA) Application for an Endolymphatic Shunt Tube With Valve | April 1, 1990 | ODE/DCRD | Do | 791 |
| Guidance for Magnetic Resonance Diagnostic Devices-Criteria for Significant Risk Investigations | September 29, 1997 | ODE/DCRD | Do | 793 |
| Draft Guidance for Preparation of PMA Applications for Testicular Prostheses | March 16, 1993 | ODE/DCRD | Do | 809 |
| Draft Guidance for Preparation of PMA Applications for Penile Inflatable Implants | March 16, 1993 | ODE/DCRD | Do | 810 |
| Draft Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis | May 30, 1997 | ODE/DCRD | Do | 842 |
| Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; Draft | May 1, 1995 | ODE/DCRD | Do | 846 |
| Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence | November 29, 1995 | ODE/DCRD | Do | 850 |
| Draft Guidance for Review of Bone Densitometer 510(k) Submissions | November 9, 1992 | ODE/DCRD | Do | 866 |
| Battery Guidance | July 12, 1993 | ODE/DCRD | Do | 873 |
| Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses; Draft | August 1, 1993 | ODE/DCRD | Do | 885 |
| 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments | September 19, 1994 | ODE/DCRD | Do | 892 |
| Draft Guidance for Hemodialyzer Reuse Labeling | October 6, 1995 | ODE/DCRD | Do | 899 |
| Hysteroscopes and Gynecology Laparoscopes-Submission Guidance for a 510(k)-Includes 00192 | March 27, 1996 | ODE/DCRD | Do | 907 |
| Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions | July 29, 1991 | ODE/DCRD | Do | 953 |
| Intravascular Brachytherapy-Guidance for Data to be Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; Draft | May 24, 1996 | ODE/DCRD | Do | 955 |
| Percutaneous Transluminal Coronary Angioplasty Package Insert Template; Draft | February 7, 1995 | ODE/DCRD | Do | 959 |
| Coronary and Cerebrovascular Guidewire Guidance | January 1, 1995 | ODE/DCRD | Do | 964 |
| Guidance for Implantable Cardioverter-Defibrillators; Draft | June 24, 1996 | ODE/DCRD | Do | 965 |
| Carotid Stent-Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications | October 26, 1996 | ODE/DCRD | Do | 974 |
| Emergency Resuscitator Guidance; Draft | April 14, 1993 | ODE/DCRD | Do | 985 |
| Review Guidelines for Oxygen Generators and Oxygen Equipment; Draft Document | April 14, 1993 | ODE/DCRD | Do | 986 |
| Draft 510(k) Checklist for Condom Catheters | February 23, 1995 | ODE/DCRD | Do | 991 |
| CDRH Interim Regulatory Policy for External Penile Rigidity Devices | September 10, 1997 | ODE/DCRD | Do | 992 |
| Reviewer Guidance on Face Masks and Shield for CPR; Draft | March 16, 1994 | ODE/DCRD | Do | 996 |
| General Guidance Document: Non-Invasive Pulse Oximeter | September 7, 1992 | ODE/DCRD | Do | 997 |
| Guidance for Peak Flow Meters for Over-the-Counter Sale | June 23, 1992 | ODE/DCRD | Do | 998 |
| 510(K) Submission Requirements for Peak Flow Meters; Draft | January 13, 1994 | ODE/DCRD | Do | 999 |
| Guidance for Industry and FDA; Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions | February 21, 2000 | ODE/DCRD | Do | 1126 |
| Guidance Document for Premarket Notification Submission for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final | January 24, 2000 | ODE/DCRD | Do | 1157 |
| Latex Condoms for Men-Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions | July 23, 1998 | ODE/DCRD | Do | 1250 |
| Guidance for Industry-Uniform Contraceptive Labeling; Final | July 23, 1998 | ODE/DCRD | Do | 1251 |
| Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final | January 17, 2000 | ODE/DCRD | Do | 1361 |
| Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final | January 16, 2000 | ODE/DCRD | Do | 177 |
| Federal Register Notice; Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft; Availability | September 10, 1998 | ODE/DCRD | Do | 1620 |
| Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) | August 1, 1995 | ODE/DCRD | Do | 1907 |
| Guidance for Industry and CDRH Reviewers-Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final | August 7, 1998 | ODE/DCRD | Do | 2202 |
| Noise Claims in Hearing Aid Labeling; Final | October 21, 1998 | ODE/DCRD | Do | 2210 |
| Guidance for Industry-Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Final | November 5, 1998 | ODE/DCRD | Do | 2232 |
| Guidance for Industry-Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final | November 5, 1998 | ODE/DCRD | Do | 2233 |
| Guidance for Industry-Harmonic Imaging With/Without Contrast-Premarket Notification; Final | November 16, 1998 | ODE/DCRD | Do | 2234 |
| Guidance for Industry-Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final | November 30, 1998 | ODE/DCRD | Do | 2235 |
| Guidance for Industry-Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final | November 20, 1998 | ODE/DCRD | Do | 2238 |
| Guidance for Industry-Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance; Version 1; Final | November 19, 1998 | ODE/DCRD | Do | 2239 |
| Guidance for Industry-Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final | December 3, 1998 | ODE/DCRD | Do | 2240 |
| Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final | February 5, 1998 | ODE/DCRD | Do | 2243 |
| Guidance for the Submission of 510(k)'s for Solid State X-Ray Imaging Devices; Final | August 6, 1999 | ODE/DCRD | Do | 644 |
| Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices | July 30, 2000 | ODE/DCRD | Do | 1138 |
| Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; Draft | November 16, 1999 | ODE Division of Dental, Infection Control and General Hospital Devices (DDIGD) | Do | 1355 |
| Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft | February 8, 2000 | ODE/DDIGD | Do | 1156 |
| Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA | March 2, 2001 | ODE/DDIGD | Do | 891 |
| Guidance on the Content and Format of Premarket Notification 510(k) Submissions of Washers and Washer-Disinfectors | June 2, 1998 | ODE/DDIGD | Do | 4 |
| Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; Final | April 21, 1999 | ODE/DDIGD | Do | 86 |
| Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for an Endosseous Implant for Prosthetic Attachment | May 16, 1989 | ODE/DDIGD | Do | 353 |
| Guidance on 510(k) Submissions for Implanted Infusion Ports | October 1, 1990 | ODE/DDIGD | Do | 392 |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles | April 1, 1993 | ODE/DDIGD | Do | 450 |
| Guidance Document on Dental Handpieces | July 1, 1995 | ODE/DDIGD | Do | 556 |
| Guidance on the Content and Format of Premarket Notification 510(k) Submissions for Liquid Chemical Germicides | December 6, 1996 | ODE/DDIGD | Do | 576 |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes | April 1, 1993 | ODE/DDIGD | Do | 821 |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers | March 1, 1993 | ODE/DDIGD | Do | 822 |
| Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps | March 1, 1993 | ODE/DDIGD | Do | 823 |
| Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters | March 16, 1995 | ODE/DDIGD | Do | 824 |
| Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities | March 1, 1993 | ODE/DDIGD | Do | 833 |
| Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities | August 1, 1993 | ODE/DDIGD | Do | 881 |
| Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes | August 1, 1993 | ODE/DDIGD | Do | 888 |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers | October 1, 1993 | ODE/DDIGD | Do | 895 |
| Draft Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices With Sharps Injury Prevention Features (Antistick) | March 1, 1995 | ODE/DDIGD | Do | 934 |
| Guidance for Industry and FDA Reviewers/Staff-Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products [Draize Testing] | January 13, 1999 | ODE/DDIGD | Do | 944 |
| Information Necessary for Premarket Notification Submissions for Screw-Type Endossesous Implants | December 9, 1996 | ODE/DDIGD | Do | 948 |
| Draft Guidance Document for the Preparation of Premarket Notification [510(k)'s] for Dental Alloys | March 3, 1997 | ODE/DDIGD | Do | 984 |
| Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints | December 1, 1995 | ODE/DDIGD | Do | 993 |
| Guidance on Premarket Notifications for Intravascular Administration Sets; Guidance for Industry and FDA Review Staff; Final | October 12, 2000 | ODE/DDIGD | Do | 1189 |
| Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities | September 19, 1995 | ODE/DDIGD | Do | 1833 |
| Groups Capable of Testing for Latex Skin Sensitization (Addendum to # 944) | July 28, 1997 | ODE/DDIGD | Do | 1944 |
| Guidance for Industry and FDA Reviewers; Neonatal and Neonatal Transport Incubators-Premarket Notifications; Final | September 18, 1998 | ODE/DDIGD | Do | 2201 |
| Dental Impression Materials-Premarket Notification; Final | August 17, 1998 | ODE/DDIGD | Do | 2203 |
| Dental Cements Premarket Notification; Final | August 18, 1998 | ODE/DDIGD | Do | 2204 |
| OTC Denture Cushions, Pads, Reliners, Repair Kits and Partially Fabricated Denture Kits; Final | August 18, 1998 | ODE/DDIGD | Do | 2205 |
| Guidance for the Preparation of a Premarket Notification [510(k)] for Direct Filling Dental Composites | November 27, 1998 | ODE/DDIGD | Do | 642 |
| Guidance and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants; Final | January 3, 2000 | ODE/DDIGD | Do | 397 |
| Class II Special Control Guidance Document: Pharmacy Compounding Devices; Final Guidance for Industry and FDA | March 12, 2001 | ODE/DDIGD | Do | 1326 |
| Guidance for Industry: Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Final | April 28, 1998 | ODE Division of General, Restorative and Neurological Devices (DGRND) | Do | 6 |
| Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants | February 21, 1997 | ODE/DGRND | Do | 33 |
| 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants | February 20, 1997 | ODE/DGRND | Do | 47 |
| Letter: Core Study for Silicone Breast Implants | January 11, 1996 | ODE/DGRND | Do | 107 |
| Protocol for Dermal Toxicity Testing for Devices in Contact With Skin (Draft) | January 1, 1985 | ODE/DGRND | Do | 124 |
| Draft Version 1-Biofeedback Devices-Draft Guidance for 510(k) Content | August 1, 1994 | ODE/DGRND | Do | 143 |
| Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices | March 28, 1995 | ODE/DGRND | Do | 180 |
| Draft Guidance Document for Femoral Stem Prostheses | August 1, 1995 | ODE/DGRND | Do | 187 |
| Draft Premarket Notification Review Guidance for Evoked Response Somatosensory Stimulators | June 1, 1994 | ODE/DGRND | Do | 207 |
| Draft Version Guide for Cortical Electrode 510(k) Content | August 10, 1992 | ODE/DGRND | Do | 208 |
| Draft Version Guidance for Clinical Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators | August 20, 1992 | ODE/DGRND | Do | 209 |
| Draft Version Cranial Perforator Guidance | July 13, 1994 | ODE/DGRND | Do | 212 |
| Draft Version Neuro Endoscope Guidance | July 7, 1994 | ODE/DGRND | Do | 214 |
| Galvanic Skin Response Measurement Devices-Draft Guidance for 510(k) Content | August 1, 1994 | ODE/DGRND | Do | 215 |
| Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament Devices | February 18, 1993 | ODE/DGRND | Do | 233 |
| Guidance for Industry, FDA Reviewers/Staff and Compliance Guidance Document for Powered Muscle Stimulator 510(k)s; Final | June 9, 1999 | ODE/DGRND | Do | 2246 |
| Guidance for Industry-Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; Final | August 30, 1999 | ODE/DGRND | Do | 54 |
| Guide for TENS 510(k) Content (Draft) | August 1, 1994 | ODE/DGRND | Do | 300 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment | July 26, 1995 | ODE/DGRND | Do | 307 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes | July 26, 1995 | ODE/DGRND | Do | 325 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise Equipment | July 26, 1995 | ODE/DGRND | Do | 326 |
| Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles | July 26, 1995 | ODE/DGRND | Do | 346 |
| Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems | January 10, 1995 | ODE/DGRND | Do | 355 |
| Guidance on the Content and Organization of a Premarket Notification for a Medical Laser | June 1, 1995 | ODE/DGRND | Do | 386 |
| Draft Guidance Document for Testing Acetabular Cup Prostheses | May 1, 1995 | ODE/DGRND | Do | 453 |
| Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft | March 18, 1998 | ODE/DGRND | Do | 487 |
| Copy of October 9, 1992, Letter and Original Suture Labeling Guidance (Reformatted 12/17/1997) | October 9, 1992 | ODE/DGRND | Do | 502 |
| Alternate Suture Labeling Resulting From the January 11, 1993, Meeting With HIMA (Reformatted 12/17/1997) | January 11, 1993 | ODE/DGRND | Do | 503 |
| Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators | February 1, 1997 | ODE/DGRND | Do | 593 |
| Draft Version-Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part 3-Implant Model | September 12, 1994 | ODE/DGRND | Do | 627 |
| Guidance for Studies for Pain Therapy Devices-General Considerations in the Design of Clinical Studies for Pain-Alleviating Devices | May 12, 1988 | ODE/DGRND | Do | 640 |
| ORDB 510(k) Sterility Review Guidance | July 3, 1997 | ODE/DGRND | Do | 659 |
| Draft Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD) | August 30, 1994 | ODE/DGRND | Do | 667 |
| Draft Outline for a Guidance Document for Testing Orthopedic Bone Cement, Request for Comments by December 10, 1993 | November 1, 1993 | ODE/DGRND | Do | 668 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Beds | July 26, 1995 | ODE/DGRND | Do | 689 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths | July 26, 1995 | ODE/DGRND | Do | 729 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables | July 26, 1995 | ODE/DGRND | Do | 735 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems | July 26, 1995 | ODE/DGRND | Do | 762 |
| Electroencephalograph Devices Guidance for 510(k) Content; Draft | November 3, 1997 | ODE/DGRND | Do | 767 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Therapeutic Massagers and Vibrators | July 26, 1995 | ODE/DGRND | Do | 818 |
| Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement (Replaces 8623 and 8093) | April 28, 1994 | ODE/DGRND | Do | 827 |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices | July 26, 1995 | ODE/DGRND | Do | 828 |
| Reviewers Guidance Checklist for Orthopedic External Fixation Devices | February 21, 1997 | ODE/DGRND | Do | 829 |
| Draft Guidance for the Preparation of Premarket Notifications [510(k)]s for Cemented, Semi-Constrained Total Knee Prostheses | April 1, 1993 | ODE/DGRND | Do | 830 |
| Draft Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements | July 16, 1997 | ODE/DGRND | Do | 832 |
| Draft 510(k) Guideline for General Surgical Electrosurgical Devices | May 10, 1995 | ODE/DGRND | Do | 904 |
| Draft Guidance for Arthroscopes and Accessory 510(k)s | May 1, 1994 | ODE/DGRND | Do | 909 |
| Guidance Document for Testing Biodegradable Polymer Implant Devices; Draft | April 20, 1996 | ODE/DGRND | Do | 914 |
| Guidance Document for Testing Bone Anchor Devices; Draft | April 20, 1996 | ODE/DGRND | Do | 915 |
| Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components; Draft | May 1, 1995 | ODE/DGRND | Do | 916 |
| Reviewers Guidance Checklist for Intramedullary Rods | February 21, 1997 | ODE/DGRND | Do | 956 |
| Draft Guidance for Testing MR Interaction With Aneurysm Clips | May 22, 1996 | ODE/DGRND | Do | 958 |
| Guidance for Industry-Guidance Document for Dura Substitute Devices; Final | August 13, 1999 | ODE/DGRND | Do | 1152 |
| Guidance Document for Surgical Lamp 510Ks; Final | July 13, 1998 | ODE/DGRND | Do | 1244 |
| Guidance for Industry-Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses; Draft | October 5, 1999 | ODE/DGRND | Do | 1354 |
| Guidance Document for the Preparation of IDEs for Spinal Systems; Final | January 13, 2000 | ODE/DGRND | Do | 2250 |
| Draft Guidance for the Preparation of an IDE Submission for a Interactive Wound and Burn Dressing | April 4, 1995 | ODE/DGRND | Do | 1817 |
| Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance-Guidance Document for Powered Suction Pump 510(k)s | October 30, 1998 | ODE/DGRND | Do | 2207 |
| Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final | March 2, 1999 | ODE/DGRND | Do | 2247 |
| Class II Special Controls Guidance Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis; Final | October 31, 2000 | ODE/DGRND | Do | 1193 |
| Guidance for Dermabrasion Devices; Final | March 2, 1999 | ODE/DGRND | Do | 2248 |
| Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing [510(k)] | May 31, 1995 | ODE/DGRND | Do | 2817 |
| Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Draft | December 16, 1999 | ODE/DGRND | Do | 1356 |
| Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord Stimulators for Pain Relief; Guidance for Industry; Draft | September 6, 2000 | ODE/DGRND | Do | 1179 |
| Guidance for Surgical Suture 510(k)s; Guidance for Industry; Final | August 10, 2000 | ODE/DGRND | Do | 1180 |
| Guidance for Neurological Embolization Devices; Guidance for Industry; Final | November 1, 2000 | ODE/DGRND | Do | 1151 |
| Guidance for Spinal System 510(k)s | September 27, 2000 | ODE/DGRND | Do | 636 |
| FDA Guidelines for Multifocal Intraocular Lens IDE Studies and PMAs | May 29, 1997 | ODE Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED) | Do | 55 |
| Announcement: Information for Manufacturers and Users of Lasers for Refractive Surgery [Excimer] | September 22, 1997 | ODE/DOED | Do | 93 |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask-Draft | January 16, 1998 | ODE/DOED | Do | 94 |
| New FDA Recommendations and Results of Contact Lens Study (7-Day Letter) | May 30, 1989 | ODE/DOED | Do | 265 |
| Draft Premarket Notification 510(k) Guidance for Contact Lens Care Products | May 1, 1997 | ODE/DOED | Do | 674 |
| Important Information About Rophae Intraocular Lenses | August 20, 1992 | ODE/DOED | Do | 811 |
| Draft Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses and 6/28, 1994, Corrections to Pages 18 and 20 | May 12, 1994 | ODE/DOED | Do | 896 |
| Retinoscope Guidance; Final | July 8, 1998 | ODE/DOED | Do | 1240 |
| Guidance for Industry-Ophthalmoscope Guidance (Direct and Indirect) | July 8, 1998 | ODE/DOED | Do | 1241 |
| Slit Lamp Guidance; Final | July 13, 1998 | ODE/DOED | Do | 1242 |
| Guidance for Industry and FDA Staff-Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval (PMA) Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final | August 11, 1998 | ODE/DOED | Do | 1249 |
| Accountability Analysis for Clinical Studies for Ophthalmic Devices; Draft | August 4, 1999 | ODE/DOED | Do | 1350 |
| Guidance on 510(k) Submissions for Keratoprostheses; Final | March 3, 1999 | ODE/DOED | Do | 1351 |
| Amendment 1: Draft Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses | June 28, 1994 | ODE/DOED | Do | 1896 |
| Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [Excimer] | October 10, 1996 | ODE/DOED | Do | 2093 |
| Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification [510(k)] | January 31, 1997 | ODE/DOED | Do | 2196 |
| Guidance Document for Nonprescription Sunglasses; Final | October 9, 1998 | ODE/DOED | Do | 2208 |
| Aqueous Shunts-510(k) Submissions; Final | November 16, 1998 | ODE/DOED | Do | 2236 |
| Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document | September 5, 1997 | ODE/DOED | Do | 7093 |
| Intraocular Lens (IOL) Guidance Document; Draft | October 14, 1999 | ODE/DOED | Do | 834 |
| Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications | August 1, 2000 | ODE/DOED | Do | 1145 |
| Guidance on Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; Final | April 10, 2000 | ODE/DOED | Do | 1134 |
| Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final | March 12, 2000 | ODE/DOED | Do | 954 |
| Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch-Draft | April 13, 1994 | ODE Division of Reproductive, Abdominal, and Radiological Devices (DRARD) | Do | 398 |
| Guidance for the Content of Premarket Notifications for Urine Drainage Bags | June 7, 1994 | ODE/DRARD | Do | 96 |
| Draft-510(k) Checklist for Conditioned Response Enuresis Alarms | November 23, 1994 | ODE/DRARD | Do | 99 |
| Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter) | May 1, 1995 | ODE/DRARD | Do | 161 |
| Draft Guidance for the Content of Premarket Notifications for Endoscopes Used in Gastroenterology and Urology | March 17, 1995 | ODE/DRARD | Do | 162 |
| Draft Guidance for the Content of Premarket Notifications for Menstrual Tampons | May 25, 1995 | ODE/DRARD | Do | 166 |
| Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence | June 6, 1995 | ODE/DRARD | Do | 189 |
| Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and Urology | June 22, 1995 | ODE/DRARD | Do | 190 |
| Guidance ("Guidelines") for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) | May 1, 1978 | ODE/DRARD | Do | 232 |
| Guidance ("Guidelines") for Evaluation of Fetal Clip Electrode | March 8, 1977 | ODE/DRARD | Do | 244 |
| Guidance ("Guidelines") for Evaluation of Tubal Occlusion Devices | November 22, 1977 | ODE/DRARD | Do | 245 |
| Guidance ("Guidelines") for Evaluation of Hysteroscopic Sterilization Devices | May 10, 1978 | ODE/DRARD | Do | 248 |
| Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document | June 14, 1997 | ODE/DRARD | Do | 298 |
| Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application For A Cochlear Implant in Children Ages 2 Through to 17 Years | May 1, 1990 | ODE/DRARD | Do | 327 |
| Guidance for Industry-Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final | November 14, 1998 | ODE/DRARD | Do | 340 |
| Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases | April 4, 1990 | ODE/DRARD | Do | 384 |
| Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements | January 18, 1991 | ODE/DRARD | Do | 418 |
| Guidance for the Content of Premarket Notifications for Conventional and Permeability Hemodialyzers; Final | August 7, 1998 | ODE/DRARD | Do | 421 |
| Guidance for the Content of Premarket Notifications for Urethral Stents | February 10, 1993 | ODE/DRARD | Do | 431 |
| Testing Guidance for Male Condoms Made From New Material (Non-Latex) | June 29, 1995 | ODE/DRARD | Do | 455 |
| Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology | February 10, 1993 | ODE/DRARD | Do | 482 |
| Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry Systems | July 29, 1994 | ODE/DRARD | Do | 490 |
| Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers | January 16, 2001 | ODE/DRARD | Do | 1164 |
| Guidance for the Submission of Premarket Notifications for Medical Image Management Devices; Guidance for Industry; Final | July 27, 2000 | ODE/DRARD | Do | 416 |
| Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final | August 9, 2000 | ODE/DRARD | Do | 1226 |
| Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources; Guidance for Industry; Final | August 2, 2000 | ODE/DRARD | Do | 1177 |
| Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA | February 16, 2001 | ODE/DRARD | Do | 983 |
| Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers | March 9, 2001 | ODE/DRARD | Do | 820 |
| Class II Special Controls Guidance Document for Clitoral Engorgement Devices; Guidance for Industry and FDA Reviewers | July 3, 2000 | ODE/DRARD | Do | 1144 |
| Thermal Endometrial Ablation Devices (Submission Guidance for an IDE); Final | March 14, 1996 | ODE/DRARD | Do | 547 |
| Draft Guidance for the Clinical Investigation of Urethral Stents | November 2, 1995 | ODE/DRARD | Do | 573 |
| Tympanostomy Tubes Submission Guidance for a 510(k) Premarket Notification; Final | January 14, 1998 | ODE/DRARD | Do | 930 |
| Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff | February 28, 2001 | ODE Program Operations Staff (POS) | Do | 310 |
| PMA/510(k) Expedited Review # G98-4 (Blue Book Memo) | March 20, 1998 | ODE/POS | Do | 7 |
| PMA/510(k) Expedited Review-Guidance for Industry and CDRH Staff [FDAMA]; Final | March 20, 1998 | ODE/POS | Do | 108 |
| Deciding When to Submit a 510(k) for a Change to an Existing Device | January 10, 1997 | ODE/POS | Do | 935 |
| A Suggested Approach to Resolving Least Burdensome Issues | September 11, 2000 | ODE/POS | Do | 1188 |
| Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA; Final; Guidance for Industry and FDA Staff | November 2, 2000 | ODE/POS | Do | 1195 |
| FDA Modernization Act of 1997 Guidance for the Device Industry on Implementation of Highest Priority Provisions [FDAMA] | February 6, 1998 | Office of Health and Industry Programs (OHIP) | Do | 434 |
| Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations to State and Local Agencies | August 13, 1998 | OHIP | Do | 1071 |
| Compliance Guidance-The Mammography Quality Standards Act Final Regulations-Preparing for MQSA Inspections | May 5, 1999 | OHIP Division of Mammography Quality and Radiation Programs (DMQRP) | Do | 6400 |
| Guidance for Submission of Request for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b)/4/8, 1998 | March 26, 1998 | OHIP/DMQRP | Do | 69 |
| Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998 | March 26, 1998 | OHIP/DMQRP | Do | 83 |
| Compliance Guidance; The Mammography Quality Standards Act Final Regulations Document # 4; Draft | September 13, 2000 | OHIP/DMQRP | Do | 1159 |
| The Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System # 2; Final Guidance for Industry and FDA (Incorporated into PGHS) | January 24, 2001 | OHIP/DMQRP | Do | 1317 |
| Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document # 3 (Incorporated into PGHS) | December 8, 1999 | OHIP/DMQRP | Do | 1496 |
| Guidance: The Mammography Quality Standards Act Final Regulations Document # 1 (Incorporated into PGHS) | March 4, 1999 | OHIP/DMQRP | Do | 1499 |
| Policy and Standard Operating Procedures When Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation Bodies | April 15, 1998 | OHIP/DMQRP | Do | 1186 |
| Guidance for Request and Issuance of Interim Notice Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b) | May 4, 1999 | OHIP/DMQRP | Do | 2217 |
| Continuing Education Credit for Reading/Writing Articles/Papers and Presenting Courses/Lectures (Incorporated into PGHS) | March 17, 1998 | OHIP/DMQRP | Do | 66206 |
| Guidance for Industry-Requalification for Interpreting Physician's Continuing Experience Requirement (Incorporated into PGHS) | May 28, 1998 | OHIP/DMQRP | Do | 66301 |
| Compliance Guidance: The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly (Incorporated into PGHS) | March 23, 1999 | OHIP/DMQRP | Do | 2256 |
| Compliance Guidance: The Mammography Quality Standards Act Final Regulations Quality Assurance Documentation (Incorporated into PGHS) | December 7, 1999 | OHIP/DMQRP | Do | 1194 |
| Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document # 2 (Incorporated into PGHS) | February 25, 2000 | OHIP/DMQRP | Do | 1498 |
| Compliance Guidance-Mammography Facility Survey, Equipment Evaluation and Medical Physicist Qualification Requirements Under MQSA; Final | November 6, 2000 | OHIP/DMQRP | Do | 6409 |
| Medical Glove Guidance Manual Draft FDA 99-4257 | August 12, 1999 | OHIP Division of Small Manufacturers Assistance (DSMA) | Do | 852 |
| Instructions for Completion of Medical Device Registration and Listing Forms FDA 2891, 2891a and 2892 | July 1, 1997 | OHIP/DSMA | Do | 12 |
| An Introduction to Medical Device Regulations (FDA 92-4222) | January 1, 1992 | OHIP/DSMA | Do | 18 |
| Regulatory Requirements for Devices for the Handicapped (FDA 87-4221) | August 1, 1987 | OHIP/DSMA | Do | 22 |
| Impact Resistant Lenses: Questions and Answers (FDA 87-4002) | September 1, 1987 | OHIP/DSMA | Do | 23 |
| Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 (Include 126) | November 29, 1996 | OHIP/DSMA | Do | 133 |
| Medical Device Appeals and Complaints: A Guidance on Dispute Resolution | February 19, 1998 | OHIP/DSMA | Do | 396 |
| Premarket Notification: 510(k)-Regulatory Requirements for Medical Devices (FDA 95-4158) [Available on Disk] | August 1, 1995 | OHIP/DSMA | Do | 469 |
| Labeling-Regulatory Requirements for Medical Devices (FDA 89-4203) | September 1, 1989 | OHIP/DSMA | Do | 470 |
| In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions (FDA 97-4224) [Available on Disk] | January 1, 1997 | OHIP/DSMA | Do | 471 |
| Investigational Device Exemptions [IDE] Manual (FDA 96-4159) DSMA [Available on Disk] | June 1, 1996 | OHIP/DSMA | Do | 472 |
| Regulation of Medical Devices; Background Information for International Officials (Entire Document Available on Disk) | April 14, 1999 | OHIP/DSMA | Do | 610 |
| Medical Device Reporting for Manufacturers [Available on Disk] | March 1, 1997 | OHIP/DSMA | Do | 987 |
| Premarket Approval (PMA) Manual | January 1, 1998 | OHIP/DSMA | Do | 1051 |
| Overview of FDA Modernization Act of 1997 Medical Device Provisions [FDAMA] | February 19, 1998 | OHIP/DSMA | Do | 1174 |
| Mutual Recognition Agreement Between the European Union and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; Draft | June 29, 2000 | OHIP/DSMA | Do | 1175 |
| Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties | February 2, 2001 | OHIP/DSMA | Do | 1160 |
| CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff | February 9, 2001 | OHIP Division of Device User Programs and Systems Analysis (DUPSA) | Do | 1323 |
| Human Factors Principles for Medical Device Labeling | September 1, 1993 | OHIP/DUPSA | Do | 227 |
| Human Factors Points to Consider for IDE Devices | January 17, 1997 | OHIP/DUPSA | Do | 839 |
| Write It Right | August 1, 1993 | OHIP/DUPSA | Do | 897 |
| Medical Device Reporting for User Facilities | April 1, 1996 | OHIP/DUPSA | Do | 989 |
| Do It By Design-An Introduction to Human Factors in Medical Devices | December 1, 1996 | OHIP/DUPSA | Do | 995 |
| Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management; Guidance for Industry and FDA Premarket and Design Control Reviewers | July 18, 2000 | OHIP/DUPSA | Do | 1497 |
| Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers | April 19, 2001 | OHIP/DUPSA | Do | 1128 |
| Perspectives on Clinical Studies for Medical Device Submissions (Statistical) | Office of Surveillance and Biometrics (OSB) Division of Biostatistics (DB) | Do | 78 | |
| PMA Review Statistical Checklist | (no date available) | OSB/DB | Do | 84 |
| Statistical Aspects of Submissions to FDA: A Medical Device Perspective (Also Includes as Appendix the Article Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions | June 1, 1984 | OSB/DB | Do | 537 |
| MDR Guidance Document: Remedial Action Exemption-E1996001; Final | July 30, 1996 | OSB/DSS | Do | 188 |
| Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Originial Equipment Manufacturer for Single Use | April 24, 2001 | OSB/DSS | Do | 1334 |
| MDR Guidance Document No. 1-IOL-E1996004; Final | August 7, 1996 | OSB/DSS | Do | 216 |
| MDR Guidance Document No. 3-Needlestick and Blood Exposure-E1996003; Final | August 9, 1996 | OSB/DSS | Do | 250 |
| Common Problems: Baseline Reports and Medwatch Form 3500A | January 1, 1997 | OSB/DSS | Do | 379 |
| MDR Reporting Guidance for Breast Implants-E1996002; Final | August 7, 1996 | OSB/DSS | Do | 452 |
| Medical Device Reporting: An Overview; Final | April 1, 1996 | OSB/DSS | Do | 509 |
| Instructions for Completing FDA Form 3500A With Coding Manual for Form 3500A (MEDWATCH)(MDR); Final | December 15, 1995 | OSB/DSS | Do | 853 |
| MEDWATCH FDA Form 3500A for Use by User Facilities, Distributors and Manufacturers for Mandatory Reporting (MDR); Final | June 1, 1993 | OSB/DSS | Do | 854 |
| Variance From Manufacturer Report Number Format [MDR Letter]; Final | July 16, 1996 | OSB/DSS | Do | 1059 |
| Instructions for Completing Form 3417: Medical Device Reporting Baseline Report [MDR]; Final | March 31, 1997 | OSB/DSS | Do | 1061 |
| MDR Internet List Server (listserv) Instruction Sheet; Final | August 29, 1996 | OSB/DSS | Do | 1094 |
| Medical Device Reporting-Alternative Summary Reporting (ASR) Program; Guidance for Industry | October 19, 2000 | OSB/DSS | Do | 315 |
| Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (MDR); Final | June 9, 1999 | OSB/DSS | Do | 1853 |
| Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads) | June 9, 1993 | OSB Issues Management Staff (IMS) | Do | 206 |
| Guidance on Criteria and Approaches for Postmarket Surveillance | November 2, 1998 | OSB/IMS | Do | 9 |
| Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies [FDAMA]; Final | February 19, 1998 | OSB/IMS | Do | 316 |
| Guidance on Procedures for Review of Postmarket Surveillance Submissions [FDAMA]; Final | February 19, 1998 | OSB/IMS | Do | 317 |
| Guidance for Industry and FDA Staff-SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols [FDAMA]; Final | November 2, 1998 | OSB/IMS | Do | 318 |
| Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; Final | March 30, 1994 | OSB/IMS | Do | 374 |
| Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket | February 2, 2000 | OSB/IMS | Do | 946 |
| Guidance on Frequently Asked Questions on Recognition of Consensus Standards [FDAMA] | December 21, 1998 | Office of Science and Technology (OST) | Do | 109 |
| Guidance on the Recognition and Use of Consensus Standards/Appendix A [FDAMA] | February 19, 1998 | OST | Do | 321 |
| A Primer on Medical Device Interactions With Magnetic Resonance Imaging Systems; Draft | February 7, 1997 | OST | Do | 952 |
| CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition | August 6, 1999 | OST | Do | 616 |
| Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problems | May 15, 1998 | OST | Do | 2000 |
| Guidance for Industry and FDA Reviewers: Guidance on Immunotoxicity Testing | May 6, 1999 | OST Division of Life Sciences (DLS) | Do | 635 |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | Date of Withdrawal | FOD No. |
|---|---|---|---|---|
| Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Draft Guidance-Not for Implementation (Replaced by Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff 8/14/00) | February 8, 2000 | OC | August 8, 2000 | 801029 |
| Guidance on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Guidance for Industry (Replaced by Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA 4/2/01) | October 18, 1999 | OC/DOEI | March 30, 2001 | 802619 |
| Final Design Control Report and Guidance (No Replacement) | June 1, 1998 | OC/DOEIII | July 24, 2000 | 800949 |
| Working Draft of the Current Good Manufacturing Practice (CGMP) Final Rule (No Replacement) | July 1, 1995 | OC/OT | April 24, 2000 | 800303 |
| Guidance on Amended Procedures for Advisory Panel Meetings [FDAMA]; Final (Replaced by Guidance on Amended Procedures for Advisory Panel Meetings, 7/22/00) | January 26, 1999 | ODE | August 4, 2000 | 800413 |
| Review Criteria for Assessment of Antimicrobial Susceptibility Devices (Replaced by Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices, 3/8/00) | May 31, 1991 | ODE/DCLD | June 16, 2000 | 800631 |
| Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to Be Used by the Consumer; Guidance for Industry; Draft (Replaced by Over-the-Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Guidance for Industry; Draft 11/14/00) | December 30, 1998 | ODE/DCLD | October 30, 2000 | 802209 |
| Guidance Document for Vascular Prostheses 510(k) Submission; Final (Replaced by Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final 11/1/00) | November 1, 2000 | ODE/DCRD | January 16, 2000 | 801357 |
| Guidance to Manufacturers on the Development of Required Postapproval Epidemiological Study Protocols for Testicular Implants (No Replacement) | Date not available | ODE/DCRD | June 15, 2000 | 800202 |
| 510(k) Reviewer Guidelines-Tracheostomy Tubes 868.5800 (No Replacement) | Date not available | ODE/DCRD | June 15, 2000 | 800550 |
| Guidance for the Comment and Review of 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices (Replaced by Guidance for the Submission of Premarket Notifications for Medical Image Management Devices; Guidance for Industry; Final 7/27/00) | August 1, 1993 | ODE/DCRD | August 8, 2000 | 800416 |
| Guidance for Industry-Guidance for the Content of Premarket Notifications [510(k)s] for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi (Replaced by Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final 8/9/00) | February 8, 1999 | ODE/DCRD | August 10, 2000 | 801226 |
| Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II (No Replacement) | February 1, 1989 | ODE/DCRD | August 30, 2000 | 800583 |
| Reviewer's Guidance for Oxygen Concentrator (No Replacement) | August 30, 1991 | ODE/DCRD | August 30, 2000 | 800781 |
| Guidance Document for Vascular Prostheses 510(k) Submission; Final (Replaced by Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final 11/1/00) | November 26, 1999 | ODE/DCRD | November 16, 2000 | 801357 |
| Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final (Replaced by Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final 11/1/00) | January 14, 2000 | ODE/DCRD | January 21, 2000 | 800372 |
| Draft Guidance for Information on Clinical Safety and Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi (Replaced by Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final 8/9/00) | February 5, 1992 | ODE/DCRD | January 10, 2001 | 800864 |
| Guidance for Annuloplasty Rings 510(k) Submissions; Final (Replaced by Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff 1/31/01) | November 26, 1999 | ODE/DCRD | February 12, 2001 | 801358 |
| Home Uterine Activity Monitors: Guidance for the Submission of 510(k) Premarket Notifications (Replaced by Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers, 3/9/01) | July 30, 1999 | ODE/DCRD | March 2001 | 800820 |
| Status Update-Information for Manufacturers Seeking Marketing Clearance of Digital Mammography Systems (Replaced by Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA 2/16/01) | February 4, 1999 | ODE/DCRD | February 27, 2001 | 800983 |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for General Purpose Disinfectants (includes Addendum of 3/9, 1994) (No Replacement) | October 1, 1993 | ODE/DDIGD | August 10, 2000 | 800902 |
| Guidance for the Preparation of Premarket Notification [510(k)] for Resorbable Periodontal Barriers (No Replacement) | April 1, 1991 | ODE/DDIGD | September 1, 2000 | 800028 |
| Guidance for Spinal System 510(k); Final (Replaced by Guidance for Spinal System 510(k)s 9/27/00) | May 7, 1999 | ODE/DGRND | October 2, 2000 | 800636 |
| Guidance for Industry-Guidance Document for Neurological Embolization Devices; Final (Replaced by Guidance for Neurological Embolization Devices; Guidance for Industry; Final 11/1/00) | August 13, 1999 | ODE/DGRND | November 7, 2000 | 801151 |
| Ophthalmic Device Triage (No Replacement) | March 19, 1998 | ODE/DOED | June 20, 2000 | 800160 |
| Announcement by Dr Alpert at 7/26, 1996, Ophthalmic Panel Meeting Concerning Manufacturers and Users of Lasers for Refractive Surgery [Excimer] (No Replacement) | August 26, 1996 | ODE/DOED | July 17, 2000 | 803093 |
| Owners Certification of Lasers as PMA Approved Devices [Excimer] (No Replacement) | September 26, 1996 | ODE/DOED | July 17, 2000 | 804093 |
| Compliance Guidance-Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA (Replaced by Compliance Guidance-Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final 11/6/00) | May 5, 1999 | OHIP/DMORP | April 8, 2000 | 806409 |
| A Pocket Guide to Device GMP Inspections-Inspections of Medical Device Manufacturers and GMP Regulation Requirements (No Replacement) | November 1, 1991 | OHIP/DSMA | June 28, 2000 | 800508 |
| Guidance for Staff, Industry, and Third Parties Implementation of Third Party Programs Under the FDA Modernization Act of 1997-June 2000; Draft (Replaced by Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties 2/2/01) | June 12, 2000 | OHIP/DSMA | February 2, 2001 | 801160 |
| Guidance for Industry-Device Use Safety: Incorporating Human Factors in Risk Management (No Replacement) | August 3, 1999 | OHIP/DUPSA | July 20, 2000 | 801497 |
| Guidance on Medical Device Patient Labeling; Final Guidance for Industry (Replaced by Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers 4/19/01) | March 3, 2000 | OHIP/DUPSA | April 9, 2001 | 801128 |
| MDR Documents Access Information for National Technical Information Service (NTIS) (No Replacement) | May 10, 1996 | OSB | June 28, 2000 | 803799 |
| Proposed Draft Guidance to Sponsors Regarding Required Postmarket Surveillance Studies of Plasma-Sprayed Porous-Coated Hip Prostheses (Archived by OSB-Replaced by Guidance Testing Metallic Plasma Sprayed Orthopedic Implants, 2/2/00) | October 7, 1994 | OSB/DPS | June 16, 2000 | 800323 |
| Letter to Manufacturers: Summary Reporting Approval for Adverse Events; Final (Replaced by Medical Device Reporting-Alternative Summary Reporting (ASR) Program; Guidance for Industry 10/19/00) | July 31, 1997 | OSB/DSS | October 30, 2000 | 800315 |
| Draft Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) (Replaced by Thermal Endometrial Ablation Devices (Submission Guidance for an IDE); Final 3/14/96)) | March 14, 1996 | ODE/DCRD | March 1996 | 800547 |
| Guidance for Review of Cases of Possible Suspension or Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998 (No Replacement) | March 26, 1998 | OHIP/DMORP | May 23, 2001 | 800080 |
| Compliance Guidance-Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA , Draft (replaced by Compliance Guidance-Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final 11/6/00 | May 5, 1999 | OHIP/DMORP | November 8, 2000 | 806409 |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | How to Obtain A Hard Copy of the Document (Name and Address, Phone, Fax, E-Mail or Internet) |
|---|---|---|---|
| Compliance Policy Guides Manual | 1998 | FDA Regulated Industries | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, NTIS Order No. PB96-920500 |
| Compliance Programs Guidance Manual | 1995 | FDA Regulated Industries | Do (NTIS Order No. PB95-915499 |
| FDA Recall Policy | 1995 | FDA Regulated Industries | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204 |
| Investigators' Operations Manual | May 1996 | FDA Regulated Industries | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB-95-913399) |
| Regulatory Procedures Manual | August 1995 | FDA Regulated Industries | Do (NTIS Order No. PB95-265534) |
| Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration "Blue Book" | 1997 | FDA Regulated Industries | Superintendent of Documents, Government Printing Office, Washington, DC 20402 |
| Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed | 1995 | Food and Animal Feed Industries | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, (NTIS Order No. PB96-920500) |
| Pesticides Analytical Manual | 1996 | Food Industry | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB94-911899) |
| FDA Advisory for Deoxynivanol (DON) in Finished Wheat Products Intended for Human Consumption and in Grain and Grain By-Products for Animal Feed | September 16, 1993 | Food and Animal Feed Industries | Office of Plant and Dairy Foods and Beverages, Food and Drug Administration (HFS-306), 200 C St. SW., Washington, DC 20204, 202-205-4681 |
| FDA's Cosmetic Labeling Manual | October 1991 | Cosmetic Industry | Food and Drug Administration, Office of Colors and Cosmetics (HFS-105), 200 C St. SW., Washington, DC 20204, 202-205-4493 |
| Statement of Policy: Foods Derived From New Plant Varieties: Notice | May 29, 1992 | Developers of New Plant Food Varieties | Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| A Food Labeling Guide | May 1997 | Food Industry | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Model Small Business Food Labeling Exemption Notice | 1998 | Food Industry | Do |
| Food Labeling: Questions and Answers | August 1994 | Food Industry | Do |
| Food Labeling: Questions and Answers: Volume II | February 1996 | Food Industry | Superintendent of Documents, Government Printing Office, Washington, DC 20420, 202-512-1800 |
| Fair Packaging and Labeling Act Manual | June 1978 | Food Industry | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650, (NTIS Order No. PB-83-222117) |
| Bacteriological Analytical Manual 7th Edition | 1992 | FDA Regulated Industries | AOAC International, 481 N. Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7077 |
| FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods | 1985 | Food Industry | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Evaluation of Milk Laboratories | 1995 | States | Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175 |
| Methods of Making Sanitation Ratings of Milk Supplies | 1999 | States | Do |
| Dry Milk Ordinance | 1995 | States | Do |
| Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers | 1999 | Dairy Industry | Do |
| Frozen Dessert Processing Guidelines | 1989 | Dairy Industry | Office of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175 |
| Pasteurized Milk Ordinance | 1999 | States | Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175 |
| Guidelines for Determining Metric Equivalents of Household Measures | October 1, 1993 | Food Industry | Office of Nutritional Products, Labeling, and Dietary Supplements, Food and Drug Administration (HFS-800), 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| List of Food Defect Action Levels (DALs) | 1995 | Food and Animal Feed Industries | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Action Levels for Poisonous or Deleterious Substances in Human Food and Feed (Also Found in CPGs) | 1995 | Food and Animal Feed Industries | Do |
| FDA Food Code | 1999 | States | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650 |
| Seafood List | 1993 | Seafood Industry | Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202-512-1800 |
| Manual of Operations National Shellfish Sanitation | 1992 | States | Office of Seafood (HFS-407), Shellfish Sanitation Branch, 200 C St. SW., Washington, DC 20204, 202-418-3150 |
| Fish and Fisheries Product Hazards and Control Guide | 1996 | Seafood Industry | Do |
| Guidance for Submitting Requests Under 21 CFR 170.39, Threshold of Regulation for Substances Used in Food Articles | 1996 | Food Packaging Industry | Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| Guidelines for the Preparation of Petition Submissions | 1996 | Food Ingredient or Packaging Industry | Do |
| Guideline for Approval of Color Additives in Contact Lenses Intended as Colors | 1996 | Color or Contact Lens Industry | Do |
| FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs or Cosmetics Use | February 1993 | Color Additives Industry | Do |
| Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations | December 1992 | Food Packaging Industry | Do |
| Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions | May 1993 | Food Packaging Industry | Do |
| Recommendations for Chemistry Data for Indirect Food Additive Petitions | June 1995 | Food Packaging Industry | Do |
| Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions | January 1993 | Food Enzyme Industry | Do |
| Estimating Exposure to Direct Food Additive and Chemical Contaminants in the Diet | September 1995 | Food and Food Ingredient Industry | Do |
| Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as Redbook I) | 1982 | Petitioners for Food or Color Additives | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 2216, (NT IS Order No. PR-83-170696 |
| Environmental Assessment Technical Handbook | March 1987 | Petitioners for Food or Color Additives | Do (NTIS Order No. PB87175345-AS, A-01) |
| Color Additive Petitions Information and Guidance | 1996 | Petitioners for Color Additives | Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| Toxological Testing of Food Additives | 1983 | Petitioners for Food or Color Additives | Do |
| List of Products for Each Product Category | October 8, 1992 | Food Industry | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers | June 10, 1996 | Food Industry | Do |
| Guidance on Labeling of Foods That Need Refrigeration by Consumers | February 24, 1997 | Food Industry | Do |
| Guidelines Concerning Notification and Testing of Infant Formula | 1985 | Infant Formula Manufacturers | Do |
| Guidelines for the Evaluation of Safety and Suitability of New Infant Formulas for Feeding Preterm Infants | 1988 | Infant Formula Manufacturers | Do |
| Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants | 1988 | Infant Formula Manufacturers | Do |
| Guidelines for the Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants With Allergic Diseases | 1990 | Infant Formula Manufacturers | Do |
| Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children and Pregnant Women With Metabolic Disorders | 1987 | Infant Formula Manufacturers | Do |
| Guidance Document for Arsenic (Trace Elements in Seafood) | January 1993 | States | Office of Seafood, Food and Drug Administration (HFS-400), 200 C St. SW., Washington, DC 20204, 202-418-3150, Internet: FDA Home Page Http://vm.cfsan.fda.gov/list.html |
| Guidance Document for Cadmium (Trace Elements in Seafood) | January 1993 | States | Do |
| Guidance Document for Chromium (Trace Elements in Seafood) | January 1993 | States | Do |
| Guidance Document for Lead (Trace Elements in Seafood) | August 1993 | States | Do |
| Guidance Document for Nickel (Trace Elements in Seafood) | January 1993 | States | Do |
| Guidance on Consultation Procedures for Foods Derived From New Plant Varieties | October 1997 | Regulated Industry | Office of Premarket Approval (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100, Internet: FDA Home Page Http://vm.cfsan.fda.gov |
| FDA's Policy for Foods Developed by Biotechnology | 1995 | Food Industry | Do |
| Bovine Spongiform Encephalopathy (BSE) in Products for Human Use | 1997 | Food Industry | Office of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175, Internet: FDA Home Page Http://www.fda.gov/opacom/morechoices/industry/guidance/gelguide.htm |
| Interim Guidance on the Voluntary Labeling of Milk and Milk Products That Have Not Been Treated With Recombinant Bovine Somatropin | February 1994 | Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168 |
| Shellfish Sanitation Model Ordinance | 1995 | States | Shellfish Program Implementation Branch, Division of Cooperative Programs, Office of Field Programs (HFS-628), 200 C St. SW., Washington, DC 20204, 202-205-8137 |
| Guide to Minimize Microbial Hazards for Fresh Fruits and Vegetables (Available in English, Spanish, Portuguese, and French) | 1998 | Farmers and Food Packers | Food Safety Initiative (HFS-32), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, or jsaltsman@bangate.fda.gov |
| Iron-Containing Supplements and Drugs: Label Warning and Unit Dose Packaging; Small Entity Compliance Guide | 1997 | Dietary Supplement Manufacturers: Small Entities | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-450), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204 |
| Partial List of Enzyme Preparations That Are Used in Foods | 1998 | FDA Regulated Industry | Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204 |
| Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food | 1998 | FDA Regulated Industry | Do |
| Fish and Fishery Products Hazards and Controls Guide, 2d Edition | January 1998 | FDA Regulated Industry | Office of Seafood (HFS-400), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204 |
| HACCP Regulations for Fish and Fishery Products: Questions and Answers | 1998 | FDA Regulated Industry | Do |
| Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body | 1998 | FDA Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-150), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204 |
| FDA Nutrition Labeling Manual, A Guide for Developing and Using Data Bases | March 1998 | FDA Regulated Industry | Do |
| HACCP Regulation for Fish and Fishery Products: Questions and Answers, Issue Three, Revised January 1999 | January 1999 | Seafood Processors | Office of Seafood (HFS-400), Center for Food Safety and Nutrition, 200 C St. SW., Washington, DC 20204, Ellen Nesheim, 202-418-3150 |
| Foods-Adulteration Involving Hard or Sharp Foreign Objects (CPG) | February 1999 | FDA Field Offices | Office of Plant and Dairy Foods and Beverages (HFS-300), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204 |
| Food Additive Petition Expedited Review | January 1999 | Guidance for Industry and Center for Food Safety and Applied Nutrition Staff | Robert L. Martin (HFS-215), OPA/CFSAN/FDA, 200 C St. SW., Washington, DC 20204, 202-418-3074, premarkt@cfsan.fda.gov or http://vm.cfsan.fda.gov/dms/opa-expe.html |
| Use of Antibiotic Resistance Marker Genes in Transgenic Plants | September 1998 | Guidance for Industry | Nega Beru (HFS-206), OPA/CFSAN/FDA, 200 C St. SW., Washington, DC 20204, 202-418-3097, premarkt@cfsan.fda.gov or http://vm.cfsan.fda.gov//dms/opa-armg.html |
| Guidance: Channels of Trade Policy for Commodities With Methyl Parathion Residues | December 2000 | Regulated Industry | Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St. SW., Washington, DC 20204, http://vm.cfsan.fda.gov/`dms |
| Draft Guidance: Fumonisin Levels in Human Foods and Animal Feeds | June 2000 | Regulated Industry | Do |
| Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide | January 1999 | Small Business Entities | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999) | December 1999 | Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Antimicrobial Food Additives | July 1999 | Regulated Industry | Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations | November 1999 | Regulated Industry | Do |
| Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations | November 1999 | Regulated Industry | Do |
| Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking | October 1999 | Small Business Entities | Division of Market Studies (HFS-726), Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, 202-401-4590 |
| Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide | September 1998 | Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Reducing Microbial Food Safety Hazards for Sprouted Seeds | October 1999 | Regulated Industry | Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064 |
| Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production | October 1999 | Regulated Industry | Do |
| Seafood HACCP Transition Policy | December 1999 | Regulated Industry | Office of Seafood (HFS-400), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-3150 |
| FDA Recommendations for Sampling and Testing Yellow Corn Shipments for Cry9C Protein Residues | January 19, 2001 | Regulated Industry | Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064 |
| Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering | January 2001 | Regulated Industry | Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| Bacteriological Analytical Manual | 2001 | Regulated Industry | Do |
| Importation of PMO Defined Dairy Products | April 11, 2000 | Dairy Industry | Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175 |
| Draft Guidance: Apple Juice, Apple Juice Concentrates, and Apple Juice Products-Adulteration with Patulin | June 2000 | Juice Industry | Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064 |
| Draft Guidance for Industry on Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products | November 2000 | Seafood Industry | Office of Seafood (HFS-400), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-3150 |
| Name of Document | Date of Issuance/Date Withdrawn | Intended User or -Regulatory Activity | How to Obtain A Hard Copy of the Document (Name and Address, Phone, Fax, E-Mail or Internet) |
|---|---|---|---|
| FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases (Replaced by 1998 update with the same title.) | 1993/June 2001 | Food Industry | Office of Nutritional Products, Labeling, and Dietary Supplements, Food and Drug Administration (HFS-800), 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Fabrication of Single Service Containers and Closures for Milk and Milk Products (Incorporated into Pasteurized Milk Ordinance as an appendix.) | 1995/June 2001 | States | Milk Safety Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | How to Obtain a Hard Copy of the Document |
|---|---|---|---|
| Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Equine (VICH GL15)-Draft | September 2000 | Animal Drug Industry | Internet via: http://www.fda.gov/cvm Communications Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, 301-827-4582, FAX 301-594-1831 |
| Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Porcine (VICH GL16)-Draft | September 2000 | Do | Do |
| Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Canine (VICH GL19)-Draft | September 2000 | Do | Do |
| Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20)-Draft | December 2000 | Do | Do |
| Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Poultry (VICH GL21)-Draft | December 2000 | Do | Do |
| Guidance for Industry: Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (VICH GL22)-Draft | December 2000 | Do | Do |
| Guidance for Industry: Safety Studies for Veterinary Drug Residues in Human Food: Genotoxicity Studies (VICH GL23)-Draft | December 2000 | Do | Do |
| Guidance for Industry: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AERs)(VICH GL24)-Draft | December 2000 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: General Recommendations (VICH GL7)-Final | March 2000 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Bovines (VICH GL12)-Final | March 2000 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Ovines (VICH GL13)-Final | March 2000 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Caprines (VICH GL14)-Final | March 2000 | Do | Do |
| Guidance for Industry: Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs)-Phase I (VICH GL6)-Final | March 2000 | Do | Do |
| Guidance for Industry: Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products (VICH GL17)-Final | March 2000 | Do | Do |
| Guidance for Industry: Good Clinical Practices (VICH GL9)-Final | May 2000 | Do | Do |
| Guidance for Industry: Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (VICH GL18)-Final | May 2000 | Do | Do |
| Guidance for Industry: How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter (NFDAs) | February 2000 | Do | Do |
| Guidance for Industry: How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes | February 2000 | Do | Do |
| Guidance for Industry: How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation | February 2000 | Do | Do |
| How to Use E-Mail to Submit Information to the Center for Veterinary Medicine-Final | February 2000 | Do | Do |
| Dioxin in Anti-Caking Agents Used in Animal Feed and Feed Ingredients | Revised April 2000 | Do | Do |
| Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds-Draft | June 2000 | Do | Do |
| The Use of Published Literature in Support of New Animal Drug Approval | November 2000 | Do | Do |
| Guidance for Industry: Bioequivalence Guidance | Revised October 2000 | Do | Do |
| Guidance for Industry # 124: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering-Draft | January 2001 | Do | Do |
| Guidance for Industry # 126: BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation, February 2001 | February 2001 | Do | Do |
| Guidance for Industry # 120: Veterinary Feed Directive Regulation | March 2001 | Do | Do |
| Guidance for Industry # 121: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims | March 2001 | Do | Do |
| Guidance for Industry and Reviewers: How the Center for Veterinary Medicine Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug-Draft | March 2001 | Do | Do |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | How to Obtain a Hard Copy of the Document |
|---|---|---|---|
| Draft Guidance for Industry; Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 | June 12, 1998 | Regulated Industry | Internet via www.fda.gov/opacom/fedregister/frexport.html or 63 FR 32219, June 12, 1998, or Office of Policy, 301-827-3360 |
| Direct Final Rule Guidance | November 21, 1997 | FDA Personnel | Internet via www.fda.gov/opacom/morechoices/industry/guidance.htm or 62 FR 62467, November 21, 1997, or Office of Policy, 301-827-3480 |
| International Harmonization; Policy on Standards | October 1995 | FDA Personnel and Regulated Industry | 60 FR 53078, October 11, 1995, or Office of Policy, 301-827-3360 |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | Date Withdrawn |
|---|---|---|---|
| FDA's Development, Issuance and Use of Guidance Documents | February 27, 1997 | FDA Personnel and Regulated Industry | September 19, 2000 |
| Small Entities Compliance Guide On: Regulations To Restrict the Sale and Distribution of Cigarettes and Smokeless Tobacco in Order to Protect Children and Adolescents (21 CFR Part 897) | February 1997 | Regulated Industry | March 31, 2000 |
| Children and Tobacco-Frequently Asked Questions About the New Regulations (Draft) | July 1997 | Regulated Industry | March 31, 2000 |
| Children and Tobacco-A Retailers Guide to the New Federal Regulations | October 1997 | Regulated Industry | March 31, 2000 |
| Children and Tobacco-A Guide to the New Federal Regulations | October 1997 | Regulated Industry | March 31, 2000 |
| Name of Document | Date of Issuance | Intended User or -Regulatory Activity | How to Obtain a Hard Copy of the Document |
|---|---|---|---|
| Compliance Policy Guide Manual-Compliance Policy Guidance for FDA Staff (Replaces Compliance Policy Guide-January 1996) | August 2000 | FDA Staff | National Technical Information Service (NTIS) 5285 Port Royal Rd., Springfield, VA 22161 or Internet at: www.fda.gov/ora/cpgm/default.html |
| Compliance Policy Guide, New Sec. 615.115 Extra-Label Use of Medicated Feeds for Minor Species | April 2001 | Do | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at: www.fda.gov/ora/compliance-;ref/rpm/rpmtc.html |
| Compliance Policy Guide, New Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens | April 2001 | Do | Do |
| Compliance Policy Guide, Reformat Sec. 220.100 Interstate Shipment of Biological Products for Use in Medical Emergencies | March 2001 | Do | Do |
| Compliance Policy Guide, Reformat Sec. 270.100 Final Container Labels-Allergenic Extracts Containing Glycerin; Reporting Changes | March 2001 | Do | Do |
| Compliance Policy Guide, Draft Sec. 230.150, Blood Donor Incentives | December 2000 | Do | Do |
| Compliance Policy Guide, Draft Distributor Medical Reporting | August 28, 1997 | FDA Staff Personnel and Regulated Industry | Do Internet at: www.fda.gov/ora/compliance-;ref/cpg-;mdr3.txt |
| Compliance Policy Guide Sec. 7150.09 Fraud, Statements of Material Facts, Bribery, and Illegal Gratuities | July 1991 | FDA Staff and Regulated Industry | Do Internet at: www.fda.gov/ora/compliance-;ref/aip-;page.html |
| Medical Device Warning Letter Pilot | March 8, 1999 | FDA Staff and Regulated Industry | Do Internet at: www.fda.gov/ohrms/Dockets/98fr/030899e.pdf |
| Glossary of Computerized System and Software Development Terminology | August 1995 | Do | National Technical Information Service (NTIS) 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-127352) or via Internet: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guidelines for Entry Review of Radiation-Emitting Electronic Devices | March 12, 1999 | FDA Staff | Division of Import Operations and Policy (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218 |
| Laboratory Procedures Manual | June 1994 | Do | Division of Field Science (HFC-141), Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857, or Internet at: www.fda.gov/ora/science-;ref/lpm/lpmtc.html |
| Laboratory Procedures Manual Chapter X, New: Method Validation Samples | May 1999 | Do | Do |
| Memorandum: ORA Investigational Strategy on Gamma-Butyrolactone (GBL) and Related Products | May 15, 2000 | Do | Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Not Available on the Internet |
| Investigations Operations Manual | January 2001 | Do | National Technical Information Service (NTIS) 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001-913399 and Internet at www.fda.gov/ora/inspect-;ref/iom/default.htm) |
| Medical Devices: Draft Guidance entitled "Guidance for FDA Staff on Civil Money Penalty Policy" | Released for Comment June 8, 1999 | FDA Staff | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420, or Internet at: http://www.fda.gov/ohrms/dockets/98fr/060899e.pdf |
| Regulatory Procedures Manual Update/New Subchapter 5 Civil Money Penalty Reduction Policy for Small Entities | April 19, 2001 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/rpm/rpmtc.html |
| Regulatory Procedures Manual New RPM Subchapter: Communication Concerning Assessment of Civil Monetary Penalties by U.S. Customs Service in Cases Involving Imported Food | January 2001 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/rpm/rpmtc.html |
| Regulatory Procedures Manual: Update, New Subchapter Application Integrity Policy | March 1998 | Do | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at: www.fda.gov/ora/compliance-;ref/rpm/rpmtc.html |
| Regulatory Procedures Manual: Update/Revision Subchapter/Priority Enforcement Strategy for Problem Importers | April 1998 | Do | Do |
| Regulatory Procedures Manual: Update/Revision Subchapter/Import Procedures | April 1998 | Do | Do |
| Regulatory Procedures Manual: Update/Revision Subchapter/Notice of Sampling | April 1998 | FDA Staff | Do |
| Regulatory Procedures Manual: Update New Subchapter/Granting and Denying Transportation and Exportation (TE) Entries | May 1998 | Do | Do |
| Regulatory Procedures Manual: Update/Revision Subchapter/Seizure | June 1998 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/rpm-;new2/ch6.html |
| Regulatory Procedures Manual: Update/Revision Subchapter/Supervisory Charges | June 1998 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/new2/ch9chgs.html |
| Regulatory Procedures Manual: New Subchapter: Civil Penalties-Electronic Product Radiation Control | July 1998 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/ch6civpen.html |
| Regulatory Procedures Manual: Update/Revision, Chapter 4, Subchapter/Warning Letters | March 21, 2000 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/rpm-;new2/ch4.html |
| Regulatory Procedures Manual New Chapter 9, Communication Concerning Assessment of Civil Monetary Penalties by U.S. Customs in Cases Involving Imported Food | January 2001 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/rpm-;new2/ch9civmonpen.html |
| Regulatory Procedures Manual New Chapter 9, Secured Storage | January 2001 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/rpm-;new2/ch9securedstorage.html |
| Guide to Inspections of Bulk Pharmaceutical Chemicals | May 1994 | Do | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB96-127154) or via Internet at: www.fda.gov/ora/inspect)-;ref/igs/iglist.html |
| Guide to Inspections of Pharmaceutical Quality Control Laboratories | July 1993 | Do | Do (NTIS Order No. PB96-127279) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories | July 1993 | Do | Do (NTIS Order No. PB96-127287) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Validation of Cleaning Processes | July 1993 | Do | Do (NTIS Order No. PB96-127246) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Lyophilization of Parenterals | July 1993 | Do | Do (NTIS Order No. PB96-127253) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of High Purity Water Systems | July 1993 | Do | Do (NTIS Order No. PB96-127261) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Dosage Form Drug Manufacturers-CGMPs | October 1993 | Do | Do (NTIS Order No. PB96-127212) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Vaccination | January 1994 | Do | Do (NTIS Order No. PB96-127345) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Topical Drug Products | July 1994 | Do | Do (NTIS Order No. PB96-127394) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Sterile Drug Substance Manufacturers | July 1994 | Do | Do (NTIS Order No. PB96-127295) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Oral Solutions and Suspensions | August 1994 | Do | Do (NTIS Order No. PB96-127147) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Nutritional Labeling and Education Act (NLEA) Requirements | February 1995 | Do | Do (NTIS Order No. PB96-127378) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Interstate Carriers and Support Facilities | April 1995 | Do | Do (NTIS Order No. PB96-127386) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Dairy Product Manufacturers | April 1995 | Do | Do (NTIS Order No. PB96-127329) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Miscellaneous Foods Vol. 1 | May 1995 | Do | Do (NTIS Order No. PB97-127220) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Miscellaneous Foods Vol. 11 | September 1996 | Do | Do (NTIS Order No. PB97-196133) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 1-Administrative Procedures/Scheduled Processes | November 1996 | Do | Do (NTIS Order No. PB97-196141) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Cosmetic Product Manufacturers | February 1995 | Do | Do (NTIS Order No. PB96-127238) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 2-Processes/ Procedures | April 1997 | Do | Do (NTIS Order No. PB97-196158) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 3-Container Closurers | July 2001 | FDA Staff | Do (NTIS Order No. PB00-133795) |
| Guide to Inspections of Blood Banks | September 1994 | Do | Do (NTIS Order No. PB96-127303) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Source Plasma Establishments | December 1994 | Do | Do (NTIS Order No. PB96-127360) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Infectious Disease Marker Testing Facilities | June 1996 | Do | Do (NTIS Order No. PB96-199476) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Biotechnology Inspections Guide | November 1991 | Do | Do (NTIS Order No. PB96-127402) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Computerized Systems in Drug Processing | February 1983 | Do | Do (NTIS Order No. PB96-127337) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Foreign Medical Device Manufacturers | September 1995 | Do | Do (NTIS Order No. PB96-127311) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Foreign Pharmaceutical Manufacturers | May 1996 | Do | Do (NTIS Order No. PB96-199468) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Mammography Quality Standards Act (MQSA) Auditors Guide | January 1998 | Do | Do (NTIS Order No. PB98-127178) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems | December 1997 | Do | Do (NTIS Order No. PB98-127152) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Acidified Food Manufacturers | May 1998 | Do | http://www.fda.gov/ora/inspect-;ref/igs/acidfgde.htm |
| Guide to Inspection of Aseptic Processing and Packaging for the Food Industry | February 2001 | Do | Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-1240 |
| Guide to Inspections of Grain Product Manufacturers | March 1998 | Do | (NTIS Order No. PB-98-137128) or via Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Bioresearch Monitoring Inspections of In Vitro Devices | February 1998 | Do | Do Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Viral Clearance Processes for Plasma Derivatives | March 1998 | Do | Do Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Trace Back of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations | April 2001 | Do | Do Internet at: www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Guide to Inspections of Computerized Systems in the Food Processing Industry | August 1998 | Do | Do Internet at: www.fda.gov/ora/inspect-;ref/igf/foodcomp.html |
| Guide to International Inspections and Travel, Revision (Formerly, FDA/ORA International Inspection Manual and Travel Guide) | July 1999 | Do | Do Revision not available on Internet |
| Guide to Inspections of Quality Systems | August 1999 | Do | Do Internet at: www.fda.gov/ora/inspect-;ref/igs/qsit/QSITGUIDE.PDF |
| Guide to Inspection of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients | April 2001 | Do | Do Internet at: http://www.fda.gov/ora/inspect-;ref/igs/iglist.html |
| Computerized Systems Used in Clinical Trials | April 1999 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/bimo/ffinalact.html |
| Compliance Program 7348.001: Bioresearch Monitoring, Human Drugs, In Vivo Bioequivalence | October 1, 1999 | D0 | Do Internet at: www.fda.gov/ora/compliance-;ref/Bimo/7348-;001/default.html |
| Good Laboratory Practice Program (Nonclinical Laboratories) 7348.808A; EPA Data Audit Inspections | October 1, 1991 | Do | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 |
| Guideline for the Monitoring of Clinical Investigators | January 1988 | FDA Regulated Industry | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 |
| Small Business Guide to FDA (FDA 96-1092) | January 1, 1996 | Do | Federal-State Relations (HFC-150), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2905 Internet at: www.fda.gov/ora/indust-;assit/default.htm |
| Compliance Program 7348.808 Bioresearch Monitoring: Good Laboratory Practices (Nonclinical) | Revised August 17, 1998 | FDA Staff | Do Internet at: www.fda.gov/ora/compliance-;ref/bimo/default.html |
| Compliance Program 7348.809 Bioresearch Monitoring: Institutional Review Board | August 18, 1994 | Do | Do |
| Compliance Program 7348.810: Sponsors, Contract Research Organizations and Monitors | Revised October 30, 1998 | Do | Do |
| Good Laboratory Practice Regulations Management Briefings | August 1979 | Do | Do Internet at: www.fda.gov/ora/compliance-;ref/bimo/default.html |
| Draft: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research | March 31, 2000 | FDA Regulated Industry | Do |
Dated: October 9, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-26650 Filed 10-23-01; 8:45 am]
BILLING CODE 4160-01-S