Notice2022-06008
Authorization of Emergency Use of Certain Medical Devices During COVID-19; 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
March 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 55 (Tuesday, March 22, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16196-16199]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1584]
Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the issuance of Emergency Use Authorizations (EUAs) (the
Authorizations) for certain medical devices related to the Coronavirus
Disease 2019 (COVID-19) public health emergency. FDA has issued the
Authorizations listed in this document under the Federal Food, Drug,
and Cosmetic Act (FD&C Act). These Authorizations contain, among other
things, conditions on the emergency use of the authorized products. The
[[Page 16197]]
Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves the virus that causes COVID-19, and the subsequent
declarations on February 4, 2020, March 2, 2020, and March 24, 2020,
that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of the virus
that causes COVID-19, personal respiratory protective devices, and
medical devices, including alternative products used as medical
devices, respectively, subject to the terms of any authorization issued
under the FD&C Act. These Authorizations, which include an explanation
of the reasons for issuance, are listed in this document, and can be
accessed on FDA's website from the links indicated.
DATES: These Authorizations are effective on their date of issuance.
ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS 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 U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------
\1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------
Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied. No other criteria for issuance have been
[[Page 16198]]
prescribed by regulation under section 564(c)(4) of the FD&C Act.
---------------------------------------------------------------------------
\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------
II. Electronic Access
An electronic version of this document and the full text of the
Authorizations are available on the internet and can be accessed from
<a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
III. The Authorizations
Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, can be accessed
from the FDA web page entitled ``Emergency Use Authorization,''
available at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
The lists that follow include Authorizations issued from September 11,
2021, through January 24, 2022, and we have included explanations of
the reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that have been reissued can be accessed
from FDA's web page: <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
FDA is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multianalyte
tests: \3\
---------------------------------------------------------------------------
\3\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the products may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the products, when used for diagnosing COVID-19, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
---------------------------------------------------------------------------
<bullet> Life Sciences Testing Center's Life Sciences Testing
Center COVID-19 Test, issued September 22, 2021;
<bullet> ANP Technologies, Inc.'s NIDS COVID-19 Antigen Rapid Test
Kit, issued September 24, 2021;
<bullet> Cleveland Clinic Robert J. Tomsich Pathology and
Laboratory Medicine Institute's SelfCheck cobas SARS-CoV-2 Assay,
issued September 29, 2021;
<bullet> ACON Laboratories, Inc.'s Flowflex COVID-19 Antigen Home
Test, issued October 4, 2021;
<bullet> Xtrava Health's SPERA COVID-19 Ag Test, issued October 12,
2021;
<bullet> LMSI, LLC's (d/b/a Lighthouse Lab Services) CovidNow SARS-
CoV-2 Assay, issued October 14, 2021;
<bullet> Celltrion USA, Inc.'s Celltrion DiaTrust COVID-19 Ag Home
Test, issued October 21, 2021;
<bullet> Detect, Inc's Detect Covid-19 Test, issued October 28,
2021;
<bullet> Talis Biomedical Corporation's Talis One COVID-19 Test
System, issued November 5, 2021;
<bullet> iHealth Labs, Inc.'s iHealth COVID-19 Antigen Rapid Test,
issued November 5, 2021;
<bullet> Meridian Bioscience, Inc.'s Revogene SARS-CoV-2, issued
November 9, 2021;
<bullet> InBios International Inc.'s SCoV-2 Ag Detect Rapid Self-
Test, issued November 22, 2021;
<bullet> Nano-Ditech Corp.'s Nano-Check COVID-19 Antigen Test,
issued December 6, 2021;
<bullet> UCSD BCG EXCITE Lab's UCSD EXCITE COVID-19 Test, issued
December 17, 2021;
<bullet> SD Biosensor, Inc.'s COVID-19 At-Home Test, issued
December 24, 2021;
<bullet> Siemens Healthineers' CLINITEST Rapid COVID-19 Antigen
Self-Test, issued December 29, 2021;
<bullet> Premier Medical Laboratory Services' PMLS SARS-CoV-2
Assay, issued January 7, 2022;
<bullet> iHealth Labs, Inc.'s iHealth COVID-19 Antigen Rapid Test
Pro, issued January 14, 2022;
<bullet> Maxim Biomedical, Inc.'s MaximBio ClearDetect COVID-19
Antigen Home Test, issued January 19, 2022; and
<bullet> Mammoth Biosciences, Inc.'s DETECTR BOOST SARS-CoV-2
Reagent Kit, issued January 21, 2022.
FDA is hereby announcing the following Authorizations for serology
tests: \4\
---------------------------------------------------------------------------
\4\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2 can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the products may be effective in diagnosing recent or prior
infection with SARS-CoV-2 by identifying individuals with an
adaptive immune response to the virus that causes COVID-19, and that
the known and potential benefits of the products when used for such
use, outweigh the known and potential risks of the products; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the products.
---------------------------------------------------------------------------
<bullet> EUROIMMUN US, Inc.'s EUROIMMUN Anti-SARS-CoV-2 S1 Curve
ELISA (IgG), issued October 4, 2021;
<bullet> InBios International, Inc.'s SCoV-2 Detect Neutralizing Ab
ELISA, issued October 22, 2021.
FDA is hereby announcing the following Authorizations for
multianalyte in vitro diagnostics:
<bullet> Laboratory Corporation of America's Labcorp SARS-CoV-2 &
Influenza A/B Assay, issued September 30, 2021; \5\
---------------------------------------------------------------------------
\5\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus RNA and that the known and potential benefits
of the product when used for diagnosing COVID-19, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------
<bullet> PerkinElmer, Inc.'s PKamp Respiratory SARS-CoV-2 RT-PCR
Panel 1, issued October 6, 2021; \6\ and
---------------------------------------------------------------------------
\6\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19, through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A, influenza
B, and/or RSV virus RNA, and that the known and potential benefits
of the product when used for diagnosing COVID-19, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------
<bullet> Applied BioCode, Inc.'s BioCode CoV-2 Flu Plus Assay,
issued December 15, 2021 \7\ FDA is hereby announcing the following
Authorizations for other medical devices:
---------------------------------------------------------------------------
\7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19, through the simultaneous qualitative
detection and differentiation of RNA from SARS-CoV-2, influenza A
virus, influenza B virus, and/or RSV, and that the known and
potential benefits of your product when used for diagnosing COVID-
19, outweigh the known and potential risks of your product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.
---------------------------------------------------------------------------
<bullet> Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics Collection Kit for COVID-19, issued October 8, 2021; \8\
---------------------------------------------------------------------------
\8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 by serving as an appropriate means to collect
and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the collected human specimen, and that
the known and potential benefits of the product when used for such
use, outweigh the known and potential risks of the product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.
---------------------------------------------------------------------------
[[Page 16199]]
<bullet> Audere's HealthPulse@home, issued November 30, 2021; \9\
---------------------------------------------------------------------------
\9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 by serving as an appropriate means to collect
and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the collected human specimen, and that
the known and potential benefits of the product when used for such
use, outweigh the known and potential risks of the product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.
---------------------------------------------------------------------------
In addition, on September 23, 2021, FDA issued a letter to
Developers of Certain Molecular, Antigen and Serology In Vitro
Diagnostics (IVDs) Authorized for Emergency Use for Coronavirus Disease
2019 (COVID-19) as of Today's Date (September 23, 2021) for
Establishing additional Conditions of Authorization for the EUAs of
Certain Molecular, Antigen and Serology IVDs related to viral
mutations.\10\
---------------------------------------------------------------------------
\10\ FDA concluded that establishing additional conditions on
the EUAs within the scope of the letter is appropriate to protect
the public health or safety and revised all such EUAs pursuant to
Section 564(g)(2)(C) of the FD&C Act to establish the three
additional conditions set forth in the letter as permitted by
Section 564(e) of the FD&C Act.
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06008 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on March 22, 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.