Notice2023-06786
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for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
April 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device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 This draft guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of machine learning- enabled medical devices and describes an approach that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 (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 This draft guidance provides recommendations on the information to be included in a Predetermined Change Control Plan (PCCP) in a marketing submission for an ML-DSF.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 This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 88 Issue 63 (Monday, April 3, 2023)</title>
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[Federal Register Volume 88, Number 63 (Monday, April 3, 2023)]
[Notices]
[Pages 19648-19650]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Device Software Functions; Draft Guidance for Industry and Food and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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device">https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device</a>.
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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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>.
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 <a href="/cdn-cgi/l/email-protection#a0e3e4f2e88de7d5c9c4c1cec3c5e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="0f4c4b5d4722487a666b6e616c6a4f696b6e2167677c21686079">[email protected]</span></a> 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
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