89 FR 163 pgs. 67945-67947 - Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Type: NOTICEVolume: 89Number: 163Pages: 67945 - 67947
Pages: 67945, 67946, 67947Docket number: [Docket No. FDA-2024-D-2338]
FR document: [FR Doc. 2024-18828 Filed 8-21-24; 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-2024-D-2338]
Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Predetermined Change Control Plans for Medical Devices." A predetermined change control plan (PCCP) is the documentation describing what modifications will be made to a device and how the modifications will be assessed. This draft guidance provides FDA's current thinking on a policy for PCCPs and recommendations on the information to include in a PCCP in a marketing submission for a device. This draft guidance is not final nor is it for implementation at this time.
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DATES:
Submit either electronic or written comments on the draft guidance by November 20, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:
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-2024-D-2338 for "Predetermined Change Control Plans for Medical 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 "Predetermined Change Control Plans for Medical 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:
Jessica Paulsen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1652, Silver Spring, MD 20993-0002, 301-796-6883, or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
While this draft guidance proposes recommendations for PCCPs, the concept of a PCCP is not entirely new to FDA. FDA has previously issued guidance related to this concept, including, for example, how changes in the expiration date for use of a device generally do not require submission of a new premarket notification (510(k)) when the same methods or protocols that are described in the previously cleared 510(k) are used to support the change;? 1 and how manufacturers may add certain additional instruments for use with an in vitro diagnostic (IVD) assay that was previously cleared for use with a specific instrument without submission of a new 510(k), in part, by conducting a risk-based assessment and design verification and/or validation activities to assess the use of the IVD assay with the new instrument(s). 2
Footnotes:
1 ? See FDA's guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device," available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
2 ? See FDA's guidance "Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices," available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/replacement-reagent-and-instrument-family-policy-in-vitro-diagnostic-devices.
[top] FDA initially introduced the term and description of a PCCP in the "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)-Discussion Paper and Request for Feedback,"? 3 which described a potential approach to premarket review of PCCPs for AI/ML-based software modifications. On December 29, 2022, section 3308 of the Food and Drug Omnibus Reform Act (FDORA) of 2022, Title III of Division FF of the Consolidated Appropriations Act, 2023, Public Law 117-328 added section 515C "Predetermined Change Control Plans for Devices" to the
Footnotes:
3 ?Available at https://www.fda.gov/media/122535/download?attachment and https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device.
4 ?Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial.
This draft guidance provides FDA's current thinking on a policy for PCCPs and recommendations on the information to include in a PCCP in a marketing submission for a device. This draft guidance recommends that a PCCP for a device describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.
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 "Predetermined Change Control Plans for 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
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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download an electronic copy of "Predetermined Change Control Plans for Devices" may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007026 and complete title to identify the guidance you are requesting.
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 |
| 860, subpart D | De Novo classification process | 0910-0844 |
| "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 |
| 820 | Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation | 0910-0073 |
| 822 | Postmarket Surveillance of Medical Devices | 0910-0449 |
| 58 | Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies | 0910-0119 |
Dated: August 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18828 Filed 8-21-24; 8:45 am]
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