Notice2022-20828
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 28, 2022
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 document related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE) entitled "Policy for Coronavirus Disease--2019 Tests During the Public Health Emergency (Revised)." FDA is issuing this guidance to provide FDA's revised enforcement policies and review priorities regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection. This document supersedes "Policy for Coronavirus Disease--2019 Tests During the Public Health Emergency (Revised)" issued November 15, 2021. The guidance identified in this notice addresses issues related to the COVID-19 PHE and has been issued in accordance with the expedited process FDA announced in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. 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
<html>
<head>
<title>Federal Register, Volume 87 Issue 187 (Wednesday, September 28, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58803-58806]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20828]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-0987]
Policy for Coronavirus Disease--2019 Tests During the Public
Health Emergency (Revised); Immediately in Effect Guidance for
Commercial Manufacturers and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance document related to the
Coronavirus Disease 2019 (COVID-19) public health emergency (PHE)
entitled ``Policy for Coronavirus Disease--2019 Tests During the Public
Health Emergency (Revised).'' FDA is issuing this guidance to provide
FDA's revised enforcement policies and review priorities regarding
certain novel coronavirus (COVID-19) tests for the duration of the
public health emergency. Rapid detection of COVID-19 cases in the
United States requires wide availability of testing to control the
spread of this highly contagious infection. This document supersedes
``Policy for Coronavirus Disease--2019 Tests During the Public Health
Emergency (Revised)'' issued November 15, 2021. The guidance identified
in this notice addresses issues related to the COVID-19 PHE and has
been issued in accordance with the expedited process FDA announced in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. 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 September 28, 2022.
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.
[[Page 58804]]
<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-2020-D-0987 for ``Policy for Coronavirus Disease--2019 Tests During
the Public Health Emergency (Revised).'' 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 Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for a single hard copy of the guidance
document entitled ``Policy for Coronavirus Disease--2019 Tests During
the Public Health Emergency (Revised)'' 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. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Toby Lowe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance entitled
``Policy for Coronavirus Disease--2019 Tests During the Public Health
Emergency (Revised),'' which supersedes the guidance of the same title
issued November 15, 2021. FDA is issuing this guidance to provide FDA's
updated enforcement policies and review priorities regarding certain
novel coronavirus (COVID-19) tests for the duration of the public
health emergency. Rapid detection of COVID-19 cases in the United
States requires wide availability of testing to control the spread of
this highly contagious infection.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360bbb-3), the FDA Commissioner may authorize the use
of unapproved medical products, or unapproved uses of approved medical
products, in certain emergency circumstances, after the HHS Secretary
has made a declaration of emergency or threat justifying authorization
of emergency use, to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by chemical, biological,
radiological, and nuclear threat agents when certain criteria are met
(emergency use authorization (EUA)). As of August 15, 2022, FDA has
authorized under EUA more than 439 tests for COVID-19, including more
than 354 diagnostic and 85 serology or other immune response tests.
Further, two molecular diagnostic COVID-19 tests have been granted
marketing authorization through the traditional device premarket review
pathways.
In the context of a public health emergency involving pandemic
infectious disease, it is critically important that tests are validated
because false results not only can negatively impact the individual
patient but also can have a broad public health impact. False positive
results for diagnostic tests, for example, can lead to unnecessary
quarantine and potential further spread when presumed positive
individuals are quarantined together, wasted contact tracing and
testing resources, and delay in accurate diagnosis and appropriate
treatment for the individual. False negative results can lead to lack
of appropriate treatment for the individual and further spread of the
disease.
FDA has continued to closely monitor the COVID-19 testing landscape
and believes it is appropriate to update its policies to reflect the
current needs of the pandemic. As explained throughout this updated
guidance, FDA intends to review the EUA requests for a smaller subset
of tests. Traditional marketing pathways remain available to all
developers and FDA encourages developers of tests that fall outside the
scope of the priorities outlined in this updated guidance to pursue
those routes. In sum, FDA has revised this guidance to update the types
of COVID-19 tests for which the Agency intends to review EUA requests,
to discuss the use of the traditional premarket review pathways for
other types of COVID-19 tests for which the Agency does not intend to
review EUA requests, and to make minor updates to the enforcement
policies.
On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------
\1\ Secretary of Health and Human Services, ``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>.
\2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: <a href="https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/">https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/</a>. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
<a href="https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic">https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic</a>.
---------------------------------------------------------------------------
[[Page 58805]]
In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at <a href="https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf">https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf</a>), FDA announced various procedures for
making available FDA guidances related to the COVID-19 PHE. The March
25, 2020, notice stated that due to the need to act quickly and
efficiently to respond to the COVID-19 PHE and to allow FDA to rapidly
disseminate Agency recommendations and policies related to COVID-19 to
industry, FDA staff, and other stakeholders, prior public participation
would not be feasible or appropriate before FDA implemented COVID-19-
related guidances. FDA will continue to issue COVID-19-related
guidances for immediate implementation without prior public comment
(see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and
Sec. 10.115(g)(2)). The guidances are available on FDA's web pages
entitled ``COVID-19-Related Guidance Documents for Industry, FDA Staff,
and Other Stakeholders'' (available at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders">https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a>) and ``Search for
FDA Guidance Documents'' (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.) Although this guidance has
been implemented immediately without prior comment, FDA will consider
all comments received and revise the guidance as appropriate (see Sec.
10.115(g)(3)).
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA. 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. Paperwork Reduction Act of 1995
This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
OMB under the Paperwork Reduction Act of 1995 (PRA). The collections of
information in the following FDA regulations and guidances have been
approved by OMB as listed in the table below. This guidance also
contains a new collection of information not approved under a current
collection. The new collection of information has been granted a public
health emergency (PHE) waiver from the PRA by the Department of Health
and Human Services (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>.
----------------------------------------------------------------------------------------------------------------
New collection covered by
21 CFR part or guidance Topic OMB control No. PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization of Medical Emergency Use 0910-0595 .........................
Products and Related Authorities; Authorization.
Guidance for Industry and Other
Stakeholders.
``Administrative Procedures for CLIA Administrative Procedures 0910-0607 .........................
Categorization; Guidance for Industry for Clinical Laboratory
and Food and Drug Administration Improvement Amendments
Staff'' and ``Recommendations for of 1988 Categorization.
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In
Vitro Diagnostic Devices; Guidance for
Industry and Food and Drug
Administration Staff''.
803.................................... Medical devices; medical 0910-0437 .........................
device reporting;
manufacturer reporting,
importer reporting, user
facility reporting,
distributor reporting.
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 Meetings Q-submissions; pre- 0910-0756 .........................
for Medical Device Submissions: The Q- submissions.
Submission Program''.
Voluntary templates to
facilitate the
preparation and
submission of an
Emergency Use
Authorization request
for various types of
COVID-19 tests.
----------------------------------------------------------------------------------------------------------------
III. Electronic Access
Persons with access to the internet may obtain the guidance at:
<bullet> FDA web page entitled ``Guidance Documents (Medical
Devices and Radiation-Emitting Products)'' 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>;
<bullet> FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/
covid-19-
[[Page 58806]]
related-guidance-documents-industry-fda-staff-and-other-stakeholders;
<bullet> FDA web page entitled ``Search for FDA Guidance
Documents'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>; or
<bullet> <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20828 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on September 28, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.