Notice2023-06291
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; 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 That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." 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 public health emergency (PHE) 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 a phased transition process with respect to devices that fall within certain enforcement policies issued during the COVID-19 PHE declared by the Secretary of Health and Human Services (the Secretary) under the Public Health Service Act (PHS Act), including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. This guidance applies to devices that fall within enforcement policies in guidances included in List 1 of this guidance. The phased transition process outlined in this guidance will begin on the "implementation date." The implementation date is the day the PHE expires or 45 days after the finalization of this guidance, whichever comes later. Because the COVID-19 section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of this guidance, or May 11, 2023, the implementation date is that date. The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends.
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 18153-18156]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2021-D-1118 and FDA-2020-D-1138]
Transition Plan for Medical Devices That Fall Within Enforcement
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public
Health Emergency; 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 That Fall Within Enforcement Policies Issued During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' 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 public health emergency (PHE) 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 a phased transition process with respect to
devices that fall within certain enforcement policies issued during the
COVID-19 PHE declared by the Secretary of Health and Human Services
(the Secretary) under the Public Health Service Act (PHS Act),
including recommendations regarding submitting a marketing submission,
as applicable, and taking other actions with respect to these devices.
This guidance applies to devices that fall within enforcement policies
in guidances included in List 1 of this guidance. The phased transition
process outlined in this guidance will begin on the ``implementation
date.'' The implementation date is the day the PHE expires or 45 days
after the finalization of this guidance, whichever comes later. Because
the COVID-19 section 319 PHE declaration is anticipated to expire at
least 45 days after the finalization of this guidance, or May 11, 2023,
the implementation date is that date. The guidances in List 1 of this
guidance will no longer be in effect after the 180-day transition
period ends.
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
[[Page 18154]]
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-1118 for ``Transition Plan for Medical Devices That Fall
Within Enforcement Policies Issued During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency'' or the Docket No. FDA-2020-D-1138
for ``Center for Devices and Radiological Health (CDRH): 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 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 That Fall Within Enforcement
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public
Health Emergency'' 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: Ryan Ortega, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4618, Silver Spring, MD 20993-0002, 240-402-2303.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, the Secretary issued a declaration of a PHE
related to COVID-19 in accordance with section 319 of the PHS Act
(section 319PHE) (42 U.S.C. 247d) and mobilized the Operating Divisions
of the Department of Health and Human Services (HHS).\1\ FDA issued
various guidance documents that describe enforcement policies for
certain devices that are intended to support the emergency response to
the COVID-19 pandemic.
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\1\ Secretary of HHS, Determination That a Public Health
Emergency Exists (hereinafter referred to as ``section 319 PHE
declaration'') (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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Given the magnitude of the response to the COVID-19 pandemic, FDA
recognizes that a phased approach may help to facilitate an orderly and
transparent transition to normal operations. The Agency is issuing this
guidance to describe FDA's general recommendations for a phased
transition process with respect to devices that fall within certain
enforcement policies issued during the COVID-19 PHE, including
recommendations regarding submitting a marketing submission, as
applicable, and taking other actions with respect to these devices.
This guidance applies to devices that fall within the enforcement
policies described in List 1 of the guidance. FDA is concurrently
issuing a companion transition guidance to describe FDA's
recommendations for devices issued Emergency Use Authorizations related
to COVID-19.
As described in this guidance, a 180-day transition period will
begin on the implementation date. The implementation date is the date
the COVID-19 section 319 PHE expires or 45 days after the finalization
of this guidance, whichever comes later. Because the COVID-19 section
319 PHE declaration is anticipated to expire at least 45 days after the
finalization of this guidance, or on May 11, 2023, the implementation
date is that date. FDA believes the phased approach over the course of
180 days following the implementation date as set forth in this
guidance can help foster compliance with applicable legal requirements
once the relevant enforcement policies are no longer in effect.
A notice of availability of the draft guidance appeared in the
Federal Register of December 23, 2021 (86 FR 72973). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including providing clarity on the 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, and revisions to example scenarios.
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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 ``Transition Plan for Medical Devices That
Fall Within Enforcement Policies Issued During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency.'' 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. Guidances Identified in List 1 of This Guidance
As part of FDA's commitment to support continuity and response
efforts to the COVID-19 pandemic, the transition plan outlined in this
guidance takes into account that the guidances in List 1 of this
guidance will no longer be in effect after the 180-day transition
period ends, or after November 7, 2023.
Generally, the guidances that set forth COVID-19-related
enforcement policies for certain devices initially stated that they
were intended to remain in effect only for the duration of the section
319 PHE declaration. As FDA announced in the Federal Register on March
13, 2023,\2\ many of these guidance documents--the guidances in List
1--have been revised to state that they are intended to continue in
effect for 180 days after the section 319 PHE declaration expires
unless a different intended duration is set forth in the finalized
version of this guidance. A different intended duration is not being
set forth in this guidance. The implementation date is the date the
section 319 PHE declaration expires, and the guidances are intended to
continue in effect for 180 days after that date.
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\2\ See ``Guidance Documents Related to Coronavirus Disease 2019
(COVID-19)'' (88 FR 15417), available at <a href="https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19">https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19</a>.
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In finalizing this guidance, FDA added the following guidances to
List 1: ``Enforcement Policy for Viral Transport Media During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)''
\3\ and ``Enforcement Policy for Face Shields, Surgical Masks, and
Respirators During the Coronavirus Disease (COVID-19) Public Health
Emergency.'' \4\ These guidances were added to help facilitate an
appropriate transition period for these devices away from the policies
adopted and operations implemented during the COVID-19 PHE to normal
operations. FDA removed the following guidances from List 1:
``Enforcement Policy for the Quality Standards of the Mammography
Quality Standards Act During the COVID-19 Public Health Emergency,''
\5\ ``Enforcement Policy for Non-Invasive Remote Monitoring Devices
Used to Support Patient Monitoring During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency (Revised),'' \6\ ``Enforcement
Policy for Face Masks and Barrier Face Coverings During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency,'' <SUP>7 8</SUP> and
``Enforcement Policy for Clinical Electronic Thermometers During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' \9\ FDA
has removed these guidances from List 1 because: (1) the policy in the
guidance should not continue in effect beyond the expiration of the
COVID-19 PHE or (2) the guidance was extended beyond the expiration of
the COVID-19 PHE and FDA intends to retain the policy with appropriate
changes. See the Federal Register notice entitled ``Guidance Documents
Related to Coronavirus Disease 2019 (COVID-19).'' \10\
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\3\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health</a>.
\4\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-shields-surgical-masks-and-respirators-during-coronavirus-disease-covid-19">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-shields-surgical-masks-and-respirators-during-coronavirus-disease-covid-19</a>.
Bifurcation of the ``Enforcement Policy for Face Masks, Barrier Face
Coverings, Face Shields, Surgical Masks, and Respirators During the
COVID-19 Public Health Emergency (Revised)'' guidance was announced
in the Federal Register notice on March 13, 2023. The guidance
relating to face shields, surgical masks, and respirators is on List
1, and the guidance related to face masks and barrier face
coverings, as noted below, is outside the scope of this guidance.
\5\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-quality-standards-mammography-quality-standards-act-during-covid-19-public-health">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-quality-standards-mammography-quality-standards-act-during-covid-19-public-health</a>.
\6\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during</a>.
\7\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public</a>.
\8\ See footnote 4.
\9\ Available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public</a>.
\10\ See footnote 2.
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III. 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
That Fall Within Enforcement Policies Issued During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency'' may send an email
request to <a href="/cdn-cgi/l/email-protection#5b181f0913761c2e323f3a35383e1b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="adeee9ffe580ead8c4c9ccc3cec8edcbc9cc83c5c5de83cac2db">[email protected]</span></a> to receive an electronic copy of
the document. Please use the document number GUI00021011 and complete
title to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
Office of Management and Budget (OMB) under the Paperwork Reduction Act
(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
21 CFR part this guidance No. 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''.
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. 2023-06291 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P
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