[Federal Register Volume 89, Number 163 (Thursday, August 22, 2024)]
[Notices]
[Pages 67945-67947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18828]


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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Predetermined Change Control Plans for Medical Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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.

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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the availability of the draft guidance entitled ``Predetermined Change 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 This draft 
guidance provides FDA's current thinking on a policy for PCCPs and 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 This draft guidance is not final nor is it for 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.

[[Page 67946]]


DATES: Submit either electronic or written comments on the draft 
guidance by November 20, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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\
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    \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.
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    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

[[Page 67947]]

Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360e-4). Section 
515C of the FD&C Act has provisions regarding PCCPs for devices 
requiring premarket approval or premarket notification. After the 
enactment of FDORA, FDA issued a draft guidance titled ``Marketing 
Submission Recommendations for a Predetermined Change Control Plan for 
Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device 
Software Functions,'' \4\ which incorporated stakeholder feedback on 
the discussion paper and reflected our initial thinking on the 
statutory change and the types of information we recommend be submitted 
in a PCCP in a marketing submission for AI/ML-enabled software 
functions.
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    \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.
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    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 [email protected] 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:

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                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
860, subpart D.................  De Novo classification        0910-0844
                                  process.
``Requests for Feedback and      Q-submissions and Early       0910-0756
 Meetings for Medical Device      Payor Feedback Request
 Submissions: The Q-Submission    Programs for Medical
 Program''.                       Devices.
800, 801, 809, and 830.........  Medical Device Labeling       0910-0485
                                  Regulations; Unique
                                  Device Identification.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
822............................  Postmarket Surveillance       0910-0449
                                  of Medical Devices.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
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    Dated: August 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18828 Filed 8-21-24; 8:45 am]
BILLING CODE 4164-01-P