Notice2023-24213
Enforcement Policy for Certain Supplements for Approved Premarket Approval or Humanitarian Device Exemption Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
November 2, 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 final guidance entitled "Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions." This guidance outlines FDA's policies and regulatory review expectations after the COVID-19 public health emergency (PHE) for certain limited modifications affecting the safety and effectiveness of a device required to have an approved PMA or the safety and probable benefit of a device required to have an approved HDE. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Full Text
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<title>Federal Register, Volume 88 Issue 211 (Thursday, November 2, 2023)</title>
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[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75291-75292]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24213]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4595]
Enforcement Policy for Certain Supplements for Approved Premarket
Approval or Humanitarian Device Exemption Submissions; 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 final guidance entitled ``Enforcement Policy
for Certain Supplements for Approved Premarket Approval (PMA) or
Humanitarian Device Exemption (HDE) Submissions.'' This guidance
outlines FDA's policies and regulatory review expectations after the
COVID-19 public health emergency (PHE) for certain limited
modifications affecting the safety and effectiveness of a device
required to have an approved PMA or the safety and probable benefit of
a device required to have an approved HDE. This guidance has been
implemented without prior comment, but it remains subject to comment in
accordance with the Agency's good guidance practices.
DATES: The announcement of the guidance is published in the Federal
Register on November 2, 2023.
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-2023-D-4595 for ``Enforcement Policy for Certain Supplements for
Approved Premarket Approval (PMA) or Humanitarian Device Exemption
(HDE) Submissions.'' 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 guidance document entitled
``Enforcement Policy for Certain Supplements for Approved Premarket
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions'' 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 or to the Office of Communication,
Outreach and Development, Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Jhumur Banik, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2448, Silver Spring, MD 20993-0002, 240-402-5239 or
Anne Taylor, 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:
[[Page 75292]]
I. Background
FDA is announcing the availability of a final guidance entitled
``Enforcement Policy for Certain Supplements for Approved Premarket
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.''
This guidance describes FDA's general recommendations for limited
modifications to devices required to have an approved PMA or HDE to
help address manufacturing limitations or supply chain disruptions.
This guidance supersedes ``Supplements for Approved Premarket Approval
(PMA) or Humanitarian Device Exemption (HDE) Submissions During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency
(Revised)'', issued in May 2020 and updated in May 2022 (COVID-19 PMA/
HDE guidance). In the Federal Register of March 13, 2023 (88 FR 15417),
FDA announced that COVID-19 PMA/HDE guidance was being revised to
continue in effect for 180 days after the expiration of the COVID-19
PHE declaration issued under the Public Health Service Act, during
which time FDA intended to further revise the guidance.
Following expiration of the PHE declaration on May 11, 2023, FDA
has continued to observe supply chain challenges and shortages of
medical devices remain widespread. Therefore, consistent with the
Federal Register of March 13, 2023, FDA is issuing this final guidance.
Although this guidance has been revised to remove any expiration date
for the enforcement policy, the Agency will continue to monitor the
situation and may make further revisions to the guidance, withdraw the
guidance, or pursue other regulatory actions, as appropriate.
FDA has determined that this guidance document presents a less
burdensome policy that is consistent with public health. This guidance
is being implemented without prior public comment because FDA has
determined that prior public participation for this less burdensome
policy is neither feasible nor appropriate (see section 701(h)(1)(C) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C)) and 21 CFR 10.115(g)(2)) because delaying this policy is
likely to exacerbate ongoing supply chain issues. This guidance
document is being implemented immediately, but it remains subject to
comment in accordance with the Agency's good guidance practices.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Enforcement Policy for Certain Supplements
for Approved Premarket Approval (PMA) or Humanitarian Device Exemption
(HDE) Submissions.'' 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 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">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Enforcement Policy for Certain Supplements for Approved Premarket
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions'' may
send an email request to <a href="/cdn-cgi/l/email-protection#f6b5b2a4bedbb1839f9297989593b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="f2b1b6a0badfb5879b96939c9197b2949693dc9a9a81dc959d84">[email protected]</span></a> to receive an
electronic copy of the document. Please use the document number
GUI00020028 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; guidance; or FDA form Topic No.
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814, subparts A through E......... Premarket approval.. 0910-0231
814, subpart H.................... Humanitarian Use 0910-0332
Devices;
Humanitarian Device
Exemption.
800, 801, and 809................. Medical Device 0910-0485
Labeling
Requirements;
Unique Device
Identification.
820............................... Current Good 0910-0073
Manufacturing
Practice; Quality
Systems.
807, subparts A through D......... Medical Device 0910-0625
Registration and
Listing.
``Fostering Medical Device Medical Devices-- 0910-0922
Improvement: FDA Activities and Voluntary
Engagement with the Voluntary Improvement Program.
Improvement Program''.
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Dated: October 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24213 Filed 11-1-23; 8:45 am]
BILLING CODE 4164-01-P
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