89 FR 15 pgs. 4307-4309 - Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Type: NOTICEVolume: 89Number: 15Pages: 4307 - 4309
Pages: 4307, 4308, 4309Docket number: [Docket No. FDA-2023-D-5430]
FR document: [FR Doc. 2024-01158 Filed 1-22-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-5430]
Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices." This draft guidance document provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface. This draft guidance is not final nor is it for implementation at this time.
DATES:
Submit either electronic or written comments on the draft guidance by March 25, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ADDRESSES:
[top] You may submit comments on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
Instructions: All submissions received must include the Docket No. FDA-2023-D-5430 for "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices." Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices" to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Limin Sun, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4430, Silver Spring, MD 20993-0002, 301-796-7056.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface. The recommendations in this document are applicable to class II and class III devices intended for orthopedic applications that contain metallic and/or calcium phosphate coatings. Specifically, this draft guidance addresses the characterization of the following coatings on orthopedic devices: (1) a metallic coating, which can be manufactured using thermal spray ( e.g., plasma spray), sintering ( e.g., sintering of powders, beads, or fiber mesh pad), chemical vapor deposition/infiltration, physical vapor deposition ( e.g., ionic plasma deposition), additive manufacturing ( e.g., electron beam manufacturing, selective laser sintering), or other methods; (2) a calcium phosphate coating, which can be manufactured by plasma spray, solution precipitation, electrochemical deposition, or other methods; and (3) a metallic and calcium phosphate dual coating, which can be manufactured using one or more of the above methods.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices." It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
II. Electronic Access
[top] Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices" may send an email request to CDRH-Guidance@fda.hhs.gov to receive
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:
| 21 CFR part or guidance | Topic | OMB control No. |
|---|---|---|
| 807, subpart E | Premarket notification | 0910-0120 |
| 814, subparts A through E | Premarket approval | 0910-0231 |
| 812 | Investigational Device Exemption | 0910-0078 |
| "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" | Q-submissions and Early Payor Feedback Request Programs for Medical Devices | 0910-0756 |
| 800, 801, 809 and 830 | Medical Device Labeling Regulations; Unique Device Identification | 0910-0485 |
| 58 | Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies | 0910-0119 |
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01158 Filed 1-22-24; 8:45 am]
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