[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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