[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1154-1156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31543]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-4488]
Artificial Intelligence-Enabled Device Software Functions:
Lifecycle Management and Marketing Submission Recommendations; Draft
Guidance for Industry and Food and Drug Administration Staff;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the availability of the draft guidance entitled ``Artificial
Intelligence Enabled Device Software Functions: Lifecycle Management
and Marketing Submission Recommendations.'' This draft guidance, when
finalized, will provide recommendations regarding the contents of
marketing submissions for devices that include artificial intelligence
(AI)-enabled device software functions including documentation and
information that will support FDA's evaluation of safety and
effectiveness. To support the development of appropriate documentation
for FDA's assessment of the device, this draft guidance also proposes
recommendations for the design, development, and implementation of AI-
enabled devices that sponsors may wish to consider using throughout the
total product lifecycle (TPLC). This draft guidance is not final nor is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DATES: Submit either electronic or written comments on the draft
guidance by April 7, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-4488 for ``Artificial Intelligence-Enabled Device Software
Functions: Lifecycle Management and Marketing Submission
Recommendations.'' 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
``Artificial Intelligence-Enabled Device Software Functions: Lifecycle
Management and Marketing Submission Recommendations'' 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: Sonja Fulmer, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5536, Silver Spring, MD 20993-0002, 240-402-5979;
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; or Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire
[[Page 1155]]
Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-0002, 301-
796-3400.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has long promoted a TPLC approach to oversight of medical
devices, including AI-enabled devices, and has committed to developing
guidances and resources for such an approach. Some recent efforts
include developing guiding principles for good machine learning
practice (GMLP) and transparency for machine learning-enabled devices
to help promote safe, effective, and high-quality machine learning
models; and a public workshop on fostering a patient-centered approach
to AI-enabled devices, including discussion of device transparency for
users. This draft guidance intends to continue these efforts, by
proposing recommendations tailored to a TPLC approach for AI-enabled
devices. This draft guidance, when finalized, will provide
recommendations regarding the contents of marketing submissions for
devices that include AI-enabled device software functions including
documentation and information that will support FDA's evaluation of
safety and effectiveness. The recommendations reflect a comprehensive
approach to the management of risk throughout the device TPLC. To
support the development of appropriate documentation for FDA's
assessment of the device, this draft guidance also proposes
recommendations for the design, development, and implementation of AI-
enabled devices that manufacturers may wish to consider using
throughout the TPLC. This draft guidance, when finalized, also will
include FDA's current thinking on strategies to address transparency
and bias throughout the TPLC of AI-enabled devices, including by
collecting evidence to evaluate whether a device benefits all relevant
demographic groups (e.g., race, ethnicity, sex, and age) similarly, to
help ensure that these devices remain safe and effective for their
intended use. These interconnected considerations are important
throughout the TPLC and should be incorporated from the earliest stages
of device development through decommission to help design transparency
into the device. Finally, this draft guidance proposes recommendations
that address the performance of AI-enabled devices in the postmarket
setting.
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 ``Artificial
Intelligence Enabled Device Software Functions: Lifecycle Management
and Marketing Submission Recommendations.'' 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. Other Considerations
The recommendations discussed within the document are based upon
FDA's experience with reviewing a diversity of AI-enabled devices and
current regulatory science research. However, FDA understands that the
development of AI is an evolving field, with experts from many
different sectors that can contribute to the development of AI-enabled
devices. FDA requests public comment from all interested stakeholders
on the following items:
How well the proposed recommendations align with the AI
lifecycle.
The adequacy of the recommended documentation to be
included in a marketing submission to address concerns that may be
raised with AI-enabled devices that use emerging technology, such as
generative AI.
The proposed approach to performance monitoring, including
use of a performance monitoring plan as a means of risk mitigation for
AI-enabled devices.
The proposed approach to the type of information that
should be conveyed to users about AI-enabled devices, including the
example model card.
III. 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. Persons unable to download an electronic copy of
``Artificial Intelligence Enabled Device Software Functions: Lifecycle
Management and Premarket Submission Recommendations'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number GUI00007028 and complete
title to identify the guidance you are requesting.
IV. 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 (44 U.S.C. 3501-3521). The collections of information in
the following table have been approved by OMB:
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21 CFR part; guidance; or FDA OMB control
form Topic No.
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807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Use 0910-0332
Devices; Humanitarian
Device Exemption.
812............................ Investigational Device 0910-0078
Exemption.
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.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
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[[Page 1156]]
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31543 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P