[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4952-4954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01426]


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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 Coronavirus 
Disease 2019 (COVID-19). 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 Authorization follows 
the February 4, 2020, determination by the Secretary of Health and 
Human Services (HHS), as amended on March 15, 2023, 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 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 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 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: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a 
toll-free number).

SUPPLEMENTARY INFORMATION:

[[Page 4953]]

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 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 April 14, 
2023, through December 8, 2023, 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

[[Page 4954]]

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 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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     Azure Biotech, Inc.'s Azure Fatep COVID-19 Antigen Pen 
Home Test, issued April 14, 2023;
     MedArbor, LLC dba MedArbor Diagnostics' MedArbor 
Diagnostics SARS-CoV-2 Assay, issued April 19, 2023;
     Princeton BioMeditech Corp's Status COVID-19 Antigen Rapid 
Test for Home Use, issued April 24, 2023;
     University of Massachusetts' ICTC SARS-CoV-2 RT-PCR Assay, 
issued April 26, 2023;
     Drexel University College of Medicine's SARS-CoV-2 DUCoM-
PDL Modified Tetracore Assay, issued on April 28, 2023;
     Access Medical Laboratories, Inc.'s Global Direct RT-PCR 
Test, issued on May 3, 2023;
     Nano-Ditech Corporation's Nano-Check COVID-19 Antigen At-
Home Test, issued on May 12, 2023;
     BioTeke USA, LLC's Bio-Self COVID-19 Antigen Home Test, 
issued on May 22, 2023;
     Acutis Diagnostics' SARS-CoV-2 Acutis Multiplex Assay, 
issued on June 06, 2023;
     Michigan State University laboratories, Department of 
Medicine Olin Student Health Center's In-Dx SARS-CoV-2 RT-LAMP Assay, 
issued on June 08, 2023;
     Discover Labs' Discover Labs COVID-19 Assay, issued on 
June 30, 2023;
     Immunostics Inc.'s Swab-N-Go Home Test COVID-19 Ag, issued 
on July 17, 2023;
     Alphadera Labs, LLC's ALPHADx SARS-COV-2RT-PCR Test, 
issued on July 20, 2023;
     Laboratory Corporation of America's Clear Dx SARS-CoV-2 
WGS v3.0 Test, issued on August 1, 2023; and
     3EO Health, Inc.'s 3EO Health COVID-19 Test, issued on 
September 19, 2023.
     Tangen Biosciences, Inc.'s TangenDx SARS-CoV-2 Molecular 
Test, issued September 29, 2023;
     SD Biosensor, Inc.'s STANDARD Q COVID-19 Ag Test 2.0, 
issued September 29, 2023;
     MAWD Laboratories' MAWD Laboratories SARS-CoV-2 Dual 
Target by RT-PCR, issued on October 13, 2023;
     RCA Laboratory Services LLC dba GENETWORx's Gx HTIQ SARS-
CoV-2 Test, issued December 08, 2023; and
     RCA Laboratory Services LLC dba GENETWORx's Gx HTKB SARS-
CoV-2 Test, issued on December 08, 2023.
    FDA is hereby announcing the following Authorizations for 
multianalyte tests:
     Princeton BioMeditech Corp's ViraDx SARS-CoV-2/Flu A+B 
Rapid Antigen Test, issued on September 8, 2023.\4\
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    \4\ As set forth in the EUA for this product, 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 detection and differentiation of SARS-CoV-2, influenza 
A virus and/or influenza B virus nucleocapsid protein antigens, and 
that the known and potential benefits of the product when used for 
diagnosing COVID-19, outweigh the known and potential risks of such 
product; and (3) there is no adequate, approved, and available 
alternative to the emergency use of the product.
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     Roche Molecular Systems's cobas SARS-CoV-2 & Influenza A/B 
v2, issued on November 16, 2023.\5\
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    \5\ As set forth in the EUA for this product, 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 such product; 
and (3) there is no adequate, approved, and available alternative to 
the emergency use of the product.

    Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01426 Filed 1-24-24; 8:45 am]
BILLING CODE 4164-01-P