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[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Lifecycle Management and Marketing Submission Recommendations; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Artificial 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 This draft guidance, when 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for FDA's assessment of the device, this draft guidance also proposes 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 This draft guidance is not final nor is 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DATES: Submit either electronic or written comments on the draft 
guidance by April 7, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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
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