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[Federal Register Volume 89, Number 233 (Wednesday, December 4, 2024)]
[Notices]
[Pages 96259-96261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28361]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2628]

Marketing Submission Recommendations for a Predetermined Change 
Control Plan for Artificial Intelligence-Enabled Device Software 
Functions; 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, Agency, or we) is 
announcing the availability of a final guidance entitled ``Marketing 
Submission Recommendations for a Predetermined Change Control Plan for 
Artificial Intelligence-Enabled Device Software Functions.'' This 
guidance demonstrates FDA's commitment to developing innovative 
approaches to the regulation of artificial intelligence (AI)-enabled 
devices. More specifically, this guidance provides recommendations on 
the information to include in a Predetermined Change Control Plan 
(PCCP) in a marketing submission for a device that includes one or more 
AI-enabled device software functions (AI-DSFs). This guidance 
recommends that a PCCP describe the planned AI-DSF 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.

DATES: The announcement of the guidance is published in the Federal 
Register on December 4, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2022-D-2628 for ``Marketing Submission Recommendations for a 
Predetermined Change Control Plan for Artificial Intelligence-Enabled 
Device Software Functions.'' 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 guidance document entitled 
``Marketing

[[Page 96260]]

Submission Recommendations for a Predetermined Change Control Plan for 
Artificial Intelligence-Enabled Device Software Functions'' to the 
Office of Policy, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Sonja Fulmer, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 240-402-5979; 
James Myers, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911; Tala Fakhouri, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6330, Silver Spring, MD 20993-0002, 301-
837-7407; or Stephanie Shapley, Office of Combination Products, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5118, 
Silver Spring, MD 20993-0002, 301-796-4836.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has a longstanding commitment to develop and apply innovative 
approaches to the regulation of medical device software and other 
digital health technologies to ensure their safety and effectiveness. 
As technology continues to advance all facets of healthcare, medical 
software incorporating AI, including the subset of AI known as machine 
learning (ML), has become an important part of many medical devices. In 
April 2019, FDA published 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.'' \1\ The 2019 discussion paper received a substantial amount 
of feedback from a wide array of interested parties that contributed to 
the development of the draft of this guidance.
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    \1\ Available at https://www.fda.gov/media/122535/download?attachment, and also at FDA's website on ``Artificial 
Intelligence and Machine Learning in Software as a Medical Device,'' 
available at https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device.
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    On December 29, 2022, section 3308 of the Food and Drug Omnibus 
Reform Act of 2022, Title III of Division FF of the Consolidated 
Appropriations Act, 2023 (FDORA) (Pub. L. 117-328), added section 515C 
``Predetermined Change Control Plans for Devices'' to the 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 (PMA) or premarket notification (510(k)). While under the FD&C 
Act FDA may approve or clear a PCCP for a variety of devices, this 
guidance provides recommendations specifically for PCCPs for AI-DSFs.
    A notice of availability of the draft guidance, under the title 
``Marketing Submission Recommendations for a Predetermined Change 
Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-
Enabled Device Software Functions,'' appeared in the Federal Register 
of April 3, 2023 (88 FR 19648). FDA considered comments received and 
revised the guidance as appropriate in response to the comments, 
including the title. In this final guidance, FDA provides additional 
clarification throughout, including related to the scope of the 
guidance, information related to the PCCP to include in labeling and 
publicly available decision summaries, implementation of a modification 
to a device consistent with an authorized PCCP, and postmarket 
surveillance recommendations. We revised the definitions of the terms 
``artificial intelligence'' and ``machine learning'' to align with 
definitions in Executive Order 14110 of October 30, 2023.\2\ In 
response to comments received, we also clarified other terminology used 
in the guidance, including clarifications for training, tuning, and 
test data.
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    \2\ E.O. 14110 of October 30, 2023, Safe, Secure, and 
Trustworthy Development and Use of Artificial Intelligence, 
available at https://www.federalregister.gov/d/2023-24283.
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    This final guidance represents the Agency's next step in working to 
develop innovative approaches tailored to AI-enabled devices. These 
recommendations are based on the statutory authorities provided in the 
FD&C Act, including the provisions added by FDORA, as well as feedback 
obtained through our various interactions with interested parties and 
through public comment on the draft of this guidance. The 
recommendations in this guidance are intended to provide a forward-
thinking approach to promote the development of safe and effective AI-
enabled devices.
    This guidance provides recommendations on the information to 
include in a PCCP in a marketing submission for a device that includes 
one or more AI-DSFs. The guidance recommends that a PCCP describe the 
planned AI-DSF 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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Marketing Submission Recommendations for a 
Predetermined Change Control Plan for Artificial Intelligence-Enabled 
Device Software Functions.'' 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 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, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. 
Persons unable to download an electronic copy of ``Marketing Submission 
Recommendations for a Predetermined Change Control Plan for Artificial 
Intelligence-Enabled Device Software Functions'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number GUI00020049 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

[[Page 96261]]

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; guidance; or FDA
             form                       Topic           OMB control No.
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807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
860, subpart D................  De Novo                        0910-0844
                                 classification
                                 process.
``Requests for Feedback and     Q-submissions and              0910-0756
 Meetings for Medical Device     Early Payor Feedback
 Submissions: The Q-Submission   Request Programs for
 Program''.                      Medical Devices.
800, 801, 809, and 830........  Medical Device                 0910-0485
                                 Labeling
                                 Regulations; Unique
                                 Device
                                 Identification.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
822...........................  Postmarket                     0910-0449
                                 Surveillance of
                                 Medical Devices.
50, 56........................  Protection of Human            0910-0130
                                 Subjects and
                                 Institutional Review
                                 Boards.
58............................  Good Laboratory                0910-0119
                                 Practice (GLP)
                                 Regulations for
                                 Nonclinical
                                 Laboratory Studies.
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    Dated: November 25, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28361 Filed 12-3-24; 8:45 am]
BILLING CODE 4164-01-P
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