[Federal Register Volume 88, Number 63 (Monday, April 3, 2023)]
[Notices]
[Pages 19648-19650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06786]


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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/Machine Learning-Enabled 
Device Software Functions; Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Marketing Submission 
Recommendations for a Predetermined Change Control Plan for Artificial 
Intelligence/Machine Learning (AI/ML)-Enabled Device Software 
Functions.'' This draft guidance demonstrates FDA's commitment to 
developing innovative approaches to the regulation of machine learning-
enabled medical devices and describes an approach that would often be 
the least burdensome and would support iterative improvement through 
modifications to machine learning-enabled device software functions

[[Page 19649]]

(herein referred to as ML-DSF) while continuing to ensure device safety 
and effectiveness. This draft guidance provides recommendations on the 
information to be included in a Predetermined Change Control Plan 
(PCCP) in a marketing submission for an ML-DSF. Such a plan describes 
the anticipated ML-DSF modifications and the associated methodology to 
implement those modifications, which would be reviewed in the marketing 
submission to ensure the continued safety and effectiveness of the 
device without necessitating additional marketing submissions for each 
modification described in the PCCP. This draft guidance is not final 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DATES: Submit either electronic or written comments on the draft 
guidance by July 3, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2022-D-2628 for ``Marketing Submission Recommendations for a 
Predetermined Change Control Plan for Artificial Intelligence/Machine 
Learning (AI/ML)-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 draft guidance document entitled 
``Marketing Submission Recommendations for a Predetermined Change 
Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-
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. 5431, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request.

FOR FURTHER INFORMATION CONTACT: Brendan O'Leary, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 301-
796-6898; Diane Maloney, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993, 240-402-8113; 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 John Weiner, Office of Combination Products, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5130, HFG-3, 
Silver Spring, MD 20993-0002, 301-796-8941.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has a longstanding commitment to developing and applying 
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, software incorporating AI, and specifically the subset of 
AI known as 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\
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    \1\ Available at https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device.

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[[Page 19650]]

    The discussion paper received a generous amount of stakeholder 
feedback that assisted in development of a tailored regulatory 
framework for AI/ML-enabled medical devices. This draft guidance, which 
was developed in response to stakeholder feedback, represents the 
Agency's next step in working to develop a tailored regulatory 
framework for ML-DSF. The discussion paper focused on a framework for 
SaMD only and introduced the term ``SaMD Pre-Specifications.'' In this 
draft guidance, the Agency is broadening the scope of the framework to 
include Software in a Medical Device (SiMD).
    Additionally, section 3308 of the Consolidated Appropriations Act, 
2023, enacted on December 29, 2022, added section 515C ``Predetermined 
Change Control Plans for Devices'' to the FD&C Act. Section 515C 
provides FDA with express authority to approve or clear PCCPs for 
devices requiring premarket approval or premarket notification. For 
example, section 515C provides that supplemental applications (section 
515C(a)) and new premarket notifications (section 515C(b)) are not 
required for a change to a device that would otherwise require a 
premarket approval supplement or new premarket notification if the 
change is consistent with a PCCP previously approved or cleared by FDA. 
Section 515C also provides that FDA may require that a PCCP include 
labeling for safe and effective use of a device as such device changes 
pursuant to such plan, notification requirements if the device does not 
function as intended pursuant to such plan, and performance 
requirements for changes made under the plan. In this draft guidance, 
we provide recommendations on the marketing submission content for 
PCCPs, which are based on the statute and feedback obtained through our 
various interactions with stakeholders.
    The purpose of this draft guidance is to promote the development of 
safe and effective medical devices that use ML models trained by ML 
algorithms. This draft guidance provides recommendations on the 
information to be included in a PCCP in a marketing submission for an 
ML-DSF. The PCCP describes the anticipated ML-DSF modifications and the 
associated methodology to implement those modifications, which would be 
reviewed in the marketing submission to assure the continued safety and 
effectiveness of the device without necessitating additional marketing 
submissions for 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 ``Marketing 
Submission Recommendations for a Predetermined Change Control Plan for 
Artificial Intelligence/Machine Learning (AI/ML)-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 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, 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/Machine Learning (AI/ML)-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 information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidance have been 
approved by OMB as listed in the following table:

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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
860, subpart D.................  De Novo classification        0910-0844
                                  process.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
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    Dated: March 28, 2023.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2023-06786 Filed 3-30-23; 8:45 am]
BILLING CODE 4164-01-P