Notice2024-18828
Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
August 22, 2024
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Predetermined Change Control Plans for Medical Devices." A predetermined change control plan (PCCP) is the documentation describing what modifications will be made to a device and how the modifications will be assessed. This draft guidance provides FDA's current thinking on a policy for PCCPs and recommendations on the information to include in a PCCP in a marketing submission for a device. This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 89 Issue 163 (Thursday, August 22, 2024)</title>
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[Federal Register Volume 89, Number 163 (Thursday, August 22, 2024)]
[Notices]
[Pages 67945-67947]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18828]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-2338]
Predetermined Change Control Plans for Medical Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;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the availability of the draft guidance entitled ``Predetermined Change
Control Plans for Medical Devices.'' A predetermined change control
plan (PCCP) is the documentation describing what modifications will be
made to a device and how the modifications will be assessed. This draft
guidance provides FDA's current thinking on a policy for PCCPs and
recommendations on the information to include in a PCCP in a marketing
submission for a device. This draft guidance is not final nor is it for
implementation at this time.
[[Page 67946]]
DATES: Submit either electronic or written comments on the draft
guidance by November 20, 2024 to ensure that the Agency considers your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-2024-D-2338 for ``Predetermined Change Control Plans for Medical
Devices.'' 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
``Predetermined Change Control Plans for Medical Devices'' 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: Jessica Paulsen, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1652, Silver Spring, MD 20993-0002, 301-
796-6883, 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.
SUPPLEMENTARY INFORMATION:
I. Background
While this draft guidance proposes recommendations for PCCPs, the
concept of a PCCP is not entirely new to FDA. FDA has previously issued
guidance related to this concept, including, for example, how changes
in the expiration date for use of a device generally do not require
submission of a new premarket notification (510(k)) when the same
methods or protocols that are described in the previously cleared
510(k) are used to support the change; \1\ and how manufacturers may
add certain additional instruments for use with an in vitro diagnostic
(IVD) assay that was previously cleared for use with a specific
instrument without submission of a new 510(k), in part, by conducting a
risk-based assessment and design verification and/or validation
activities to assess the use of the IVD assay with the new
instrument(s).\2\
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\1\ See FDA's guidance ``Deciding When to Submit a 510(k) for a
Change to an Existing Device,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a>.
\2\ See FDA's guidance ``Replacement Reagent and Instrument
Family Policy for In Vitro Diagnostic Devices,'' available at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/replacement-reagent-and-instrument-family-policy-in-vitro-diagnostic-devices">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/replacement-reagent-and-instrument-family-policy-in-vitro-diagnostic-devices</a>.
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FDA initially introduced the term and description of a PCCP in 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,'' \3\ which
described a potential approach to premarket review of PCCPs for AI/ML-
based software modifications. On December 29, 2022, section 3308 of the
Food and Drug Omnibus Reform Act (FDORA) of 2022, Title III of Division
FF of the Consolidated Appropriations Act, 2023, Public Law 117-328
added section 515C ``Predetermined Change Control Plans for Devices''
to the
[[Page 67947]]
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 or premarket notification. After the
enactment of FDORA, FDA issued a draft guidance titled ``Marketing
Submission Recommendations for a Predetermined Change Control Plan for
Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device
Software Functions,'' \4\ which incorporated stakeholder feedback on
the discussion paper and reflected our initial thinking on the
statutory change and the types of information we recommend be submitted
in a PCCP in a marketing submission for AI/ML-enabled software
functions.
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\3\ Available at <a href="https://www.fda.gov/media/122535/download?attachment">https://www.fda.gov/media/122535/download?attachment</a> and <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>.
\4\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial</a>.
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This draft guidance provides FDA's current thinking on a policy for
PCCPs and recommendations on the information to include in a PCCP in a
marketing submission for a device. This draft guidance recommends that
a PCCP for a device describe the planned device 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 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
``Predetermined Change Control Plans for Devices.'' 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>, or <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>. Persons unable to download
an electronic copy of ``Predetermined Change Control Plans for
Devices'' may send an email request to <a href="/cdn-cgi/l/email-protection#337077617b1e74465a57525d5056735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="9bd8dfc9d3b6dceef2fffaf5f8fedbfdfffab5f3f3e8b5fcf4ed">[email protected]</span></a> to
receive an electronic copy of the document. Please use the document
number GUI00007026 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. 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:
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OMB control
21 CFR part or guidance 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.
``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.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
822............................ Postmarket Surveillance 0910-0449
of Medical Devices.
58............................. Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical Laboratory
Studies.
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Dated: August 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18828 Filed 8-21-24; 8:45 am]
BILLING CODE 4164-01-P
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