Document ID: FDA-2023-D-4595-0001
Agency: fda
Document Type: Notice
Title: Enforcement Policy for Certain Supplements for Approved Premarket
Approval or Humanitarian Device Exemption Submissions; Guidance for
Industry and Food and Drug Administration Staff; Availability
Posted Date: 2023-11-02T04:00Z

[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75291-75292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 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 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 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 
``Enforcement Policy for Certain Supplements for Approved Premarket 
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions'' may 
send an email request to [email protected] 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