Notice2023-06292
Transition Plan for Medical Devices Issued Emergency Use Authorizations Related to Coronavirus Disease 2019 (COVID-19); Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff; Availability
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Published
March 27, 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 a final guidance entitled "Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)." FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 pandemic to "normal operations." To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for this transition process with respect to devices issued EUAs related to COVID-19, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices.
Full Text
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<title>Federal Register, Volume 88 Issue 58 (Monday, March 27, 2023)</title>
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[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18144-18146]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06292]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1149]
Transition Plan for Medical Devices Issued Emergency Use
Authorizations Related to Coronavirus Disease 2019 (COVID-19); Guidance
for Industry, Other Stakeholders, 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 a final guidance entitled ``Transition Plan for
Medical Devices Issued Emergency Use Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID-19).'' FDA recognizes that it will take
time for device manufacturers, device distributors, healthcare
facilities, healthcare providers, patients, consumers, and FDA to
adjust from policies adopted and operations implemented during the
COVID-19 pandemic to ``normal operations.'' To provide a clear policy
for all stakeholders and FDA staff, the Agency is issuing this guidance
to describe FDA's general recommendations for this transition process
with respect to devices issued EUAs related to COVID-19, including
recommendations regarding submitting a marketing submission, as
applicable, and taking other actions with respect to these devices.
DATES: The announcement of the guidance is published in the Federal
Register on March 27, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2021-D-1149 for ``Transition Plan for Medical Devices Issued
Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019
(COVID-19).'' 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
[[Page 18145]]
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
``Transition Plan for Medical Devices Issued Emergency Use
Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)''
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: Jacqueline Gertz, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002, 240-
402-9677.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, the Secretary of Health and Human Services
(the Secretary) issued a declaration of a public health emergency (PHE)
related to COVID-19 in accordance with section 319 of the Public Health
Service Act (section 319 PHE) (42 U.S.C. 247d) and mobilized the
Operating Divisions of the Department of Health and Human Services
(HHS).\1\ Pursuant to section 564 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), on February 4, 2020, the
Secretary determined that there is a PHE that has significant potential
to affect national security or the health and security of U.S. citizens
living abroad, and that involves the SARS-CoV-2 virus that causes
COVID-19. On the basis of such determination, the Secretary declared on
that same day, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
the SARS-CoV-2 virus that causes COVID-19 (85 FR 7316). Based on the
February 4, 2020, determination, the Secretary issued two more
declarations justifying emergency uses related to devices: on March 2,
2020, for certain personal respiratory protective devices (85 FR
13907), and on March 24, 2020, for devices, including alternative
products used as devices (85 FR 17335). On March 15, 2023, the
Secretary amended the February 4, 2020 determination to recognize the
fact that there is ``a public health emergency, or a significant
potential for a public health emergency, that affects, or has a
significant potential to affect, national security or the health and
security of United States citizens living abroad . . .'' and that
involves the SARS-CoV-2 virus that causes COVID-19 (emphasis added) (88
FR 16644).
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\1\ Secretary of HHS, Determination that a Public Health
Emergency Exists (originally issued on January 31, 2020, and
subsequently renewed), available at <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx</a>. On February 9, 2023, the
Secretary renewed the section 319 PHE declaration related to COVID-
19, effective February 11, 2023. The section 319 PHE declaration
related to COVID-19 is anticipated to expire at the end of the day
on May 11, 2023. See the HHS ``Fact Sheet: COVID-19 Public Health
Emergency Transition Roadmap,'' (February 9, 2023), available at
<a href="https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html">https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html</a>.
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Section 564 of the FD&C Act authorizes FDA, after the Secretary has
made a declaration of emergency or threat justifying authorization of
emergency use, to authorize the emergency use of an unapproved product
or an unapproved use of an approved product for certain emergency
circumstances. FDA may issue an EUA to allow a product to be used to
diagnose, treat, or prevent a serious or life-threatening disease or
condition referenced in the EUA declaration, when the statutory
criteria are met, including FDA's determination that, based on the
totality of scientific evidence, the product may be effective for such
use, the known and potential benefits outweigh the known and potential
risks for such use, and that there are no adequate, approved, and
available alternatives.
An EUA issued under section 564 of the FD&C Act remains in effect
for the duration of the relevant EUA declaration, unless the EUA is
revoked because the criteria for issuance are no longer met or
revocation is appropriate to protect public health or safety (see
section 564(f) through (g) of the FD&C Act).
Given the magnitude of the response to the COVID-19 pandemic,
including the number of devices issued EUAs, FDA recognizes that
stakeholders may need time to adjust after the termination of the
device EUA declarations to help to ensure an orderly and transparent
transition to ``normal operations.'' The Agency is issuing this
guidance to describe FDA's general recommendations for this transition
process with respect to devices issued EUAs related to COVID-19,
including recommendations regarding submitting a marketing submission,
as applicable, and taking other actions with respect to these devices.
FDA is concurrently issuing a companion transition guidance to describe
FDA's recommendations for devices that fall within certain enforcement
policies issued during the section 319 PHE related to COVID-19.
This guidance applies to devices that have been issued an EUA under
section 564 of the FD&C Act on the basis of a device EUA declaration
related to COVID-19. This guidance does not apply to devices for which
FDA has revoked the EUA under section 564(g)(2)(B) through (C) of the
FD&C Act because the criteria under section 564(c) of the FD&C Act were
no longer met or because other circumstances made such revocation
appropriate to protect the public health or safety.
HHS intends to publish the advance notice of termination of each
EUA declaration pertaining to devices in the Federal Register 180 days
before the day on which the EUA declaration is terminated. The advance
notice of termination of each device EUA declaration may occur
simultaneously or at different times, depending on whether the
circumstances underlying such declarations continue to exist (section
564(b)(2)(A) of the FD&C Act).
A notice of availability of the draft guidance appeared in the
Federal Register of December 23, 2021 (86 FR 72978). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including revising the recommendation for interim
labeling during the time when the device EUA declaration has been
terminated and a manufacturer's marketing submission for a device is
under FDA review, providing clarity on recommendations regarding
physical and/or electronic copies of updated labeling, and adding
clarifications regarding use of real-world evidence in marketing
submissions, interactions with FDA, collaboration with stakeholders on
the transition process, in vitro diagnostics, and example scenarios.
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 the ``Transition Plan for Medical Devices
Issued Emergency Use Authorizations (EUAs) Related to Coronavirus
Disease 2019 (COVID-19).'' 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.
[[Page 18146]]
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> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Transition Plan for Medical Devices
Issued Emergency Use Authorizations (EUAs) Related to Coronavirus
Disease 2019 (COVID-19)'' may send an email request to <a href="/cdn-cgi/l/email-protection#eaa9aeb8a2c7ad9f838e8b84898faa8c8e8bc4828299c48d859c"><span class="__cf_email__" data-cfemail="febdbaacb6d3b98b979a9f909d9bbe989a9fd096968dd0999188">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number GUI00020042 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA). The collections of information in the following FDA
regulations and guidance have been approved by OMB as listed in the
table below.
This guidance also contains new collections of information not
approved under a current collection. These new collections of
information have been granted a PHE waiver from the PRA by HHS on March
19, 2020, under section 319(f) of the PHS Act. Information concerning
the PHE PRA waiver can be found on the HHS website at <a href="https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers">https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers</a>.
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Another guidance referenced in OMB control New collection covered
CFR cite referenced in this guidance this guidance No(s). by PHE PRA waiver
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``Emergency Use Authorization 0910-0595
of Medical Products and
Related Authorities; Guidance
for Industry and Other
Stakeholders''.
``Requests for Feedback and 0910-0756
Meetings for Medical Device
Submissions: The Q-Submission
Program Guidance for Industry
and Food and Drug
Administration Staff''.
``Administrative Procedures 0910-0607
for CLIA Categorization'' and
``Recommendations for
Clinical Laboratory
Improvement Amendments of
1988 (CLIA) Waiver
Applications for
Manufacturers of In Vitro
Diagnostic Devices--Guidance
for Industry and FDA Staff''.
800, 801, and 809..................... .............................. 0910-0485
803................................... .............................. 0910-0437
806................................... .............................. 0910-0359
807, subparts A through D............. .............................. 0910-0625
807, subpart E........................ .............................. 0910-0120
812................................... .............................. 0910-0078
814, subparts A through E............. .............................. 0910-0231
814, subpart H........................ .............................. 0910-0332
820................................... .............................. 0910-0073
830 and 801.20........................ .............................. 0910-0720
860, subpart D........................ .............................. 0910-0844
Notification of Intent.
Transition
Implementation Plan.
Labeling Mitigation for
Certain Reusable
Devices.
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Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06292 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P
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