[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16196-16199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06008]


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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.

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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

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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.
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    \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.
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    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

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prescribed by regulation under section 564(c)(4) of the FD&C Act.
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    \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.
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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 
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

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 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. 
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: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    FDA is hereby announcing the following Authorizations for molecular 
diagnostic and antigen tests for COVID-19, excluding multianalyte 
tests: \3\
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    \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.
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     Life Sciences Testing Center's Life Sciences Testing 
Center COVID-19 Test, issued September 22, 2021;
     ANP Technologies, Inc.'s NIDS COVID-19 Antigen Rapid Test 
Kit, issued September 24, 2021;
     Cleveland Clinic Robert J. Tomsich Pathology and 
Laboratory Medicine Institute's SelfCheck cobas SARS-CoV-2 Assay, 
issued September 29, 2021;
     ACON Laboratories, Inc.'s Flowflex COVID-19 Antigen Home 
Test, issued October 4, 2021;
     Xtrava Health's SPERA COVID-19 Ag Test, issued October 12, 
2021;
     LMSI, LLC's (d/b/a Lighthouse Lab Services) CovidNow SARS-
CoV-2 Assay, issued October 14, 2021;
     Celltrion USA, Inc.'s Celltrion DiaTrust COVID-19 Ag Home 
Test, issued October 21, 2021;
     Detect, Inc's Detect Covid-19 Test, issued October 28, 
2021;
     Talis Biomedical Corporation's Talis One COVID-19 Test 
System, issued November 5, 2021;
     iHealth Labs, Inc.'s iHealth COVID-19 Antigen Rapid Test, 
issued November 5, 2021;
     Meridian Bioscience, Inc.'s Revogene SARS-CoV-2, issued 
November 9, 2021;
     InBios International Inc.'s SCoV-2 Ag Detect Rapid Self-
Test, issued November 22, 2021;
     Nano-Ditech Corp.'s Nano-Check COVID-19 Antigen Test, 
issued December 6, 2021;
     UCSD BCG EXCITE Lab's UCSD EXCITE COVID-19 Test, issued 
December 17, 2021;
     SD Biosensor, Inc.'s COVID-19 At-Home Test, issued 
December 24, 2021;
     Siemens Healthineers' CLINITEST Rapid COVID-19 Antigen 
Self-Test, issued December 29, 2021;
     Premier Medical Laboratory Services' PMLS SARS-CoV-2 
Assay, issued January 7, 2022;
     iHealth Labs, Inc.'s iHealth COVID-19 Antigen Rapid Test 
Pro, issued January 14, 2022;
     Maxim Biomedical, Inc.'s MaximBio ClearDetect COVID-19 
Antigen Home Test, issued January 19, 2022; and
     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\
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    \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.
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     EUROIMMUN US, Inc.'s EUROIMMUN Anti-SARS-CoV-2 S1 Curve 
ELISA (IgG), issued October 4, 2021;
     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:
     Laboratory Corporation of America's Labcorp SARS-CoV-2 & 
Influenza A/B Assay, issued September 30, 2021; \5\
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    \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.
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     PerkinElmer, Inc.'s PKamp Respiratory SARS-CoV-2 RT-PCR 
Panel 1, issued October 6, 2021; \6\ and
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    \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.
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     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:
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    \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.
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     Quest Diagnostics Infectious Disease, Inc.'s Quest 
Diagnostics Collection Kit for COVID-19, issued October 8, 2021; \8\
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    \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.

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     Audere's [email protected], issued November 30, 2021; \9\
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    \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.
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    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\
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    \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


