[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Pages 3995-3997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01180]


-----------------------------------------------------------------------

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 
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

[[Page 3996]]

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 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 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 
https://www.fda.gov/emergency-

[[Page 3997]]

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 June 16, 2022, 
through December 6, 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\
---------------------------------------------------------------------------

    \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.

 Genabio Diagnostics Inc.'s Genabio COVID-19 Rapid Self-Test 
Kit, issued July 8, 2022;
 Watmind USA's Speedy Swab Rapid COVID-19 Antigen Self-Test, 
issued July 8, 2022;
 Predicine, Inc.'s Predicine SARS-CoV-2 RT-PCR Test, issued 
July 19, 2022;
 Aptitude Medical Systems Inc.'s Metrix COVID-19 Test, issued 
October 18, 2022;
 Nanobiosym Precision Testing Services's The Nano Test for 
COVID-19, issued November 8, 2022;
 ANP Technologies, Inc.'s NIDS COVID-19 Antigen Home Test, 
issued November 17, 2022;
 Beijing Hotgen Biotech Co., Ltd.'s Hotgen COVID-19 Antigen 
Home Test, issued November 17, 2022;
 Premier Medical Laboratory Services's Diversified Medical 
Healthcare SARS-CoV-2 Assay, issued November 18, 2022;
 CorDx, Inc.'s CorDx COVID-19 Ag Test, issued November 21, 
2022;
 Azure Biotech Inc.'s Fastep COVID-19 Antigen Home Test, issued 
November 21, 2022;
 ACON Laboratories, Inc.'s Flowflex COVID-19 Antigen Rapid 
Test, issued December 6, 2022.

    FDA is hereby announcing the following Authorization for a 
multianalyte test:

 Lucira Health, Inc.'s Lucira COVID-19 and Flu Test, issued 
November 22, 2022.\4\
---------------------------------------------------------------------------

    \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 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.

    FDA is hereby announcing the following Authorization for a serology 
---------------------------------------------------------------------------
test:

 Diazyme Laboratories, Inc.'s Diazyme SARS-CoV-2 Neutralizing 
Antibody CLIA Kit, issued December 6, 2022.\5\
---------------------------------------------------------------------------

    \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 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 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 November 1, 2022, FDA issued a letter to Developers 
of Antigen In Vitro Diagnostics (IVDs) Authorized for Emergency Use for 
Coronavirus Disease 2019 (COVID-19) as of Today's Date (November 1, 
2022) for Revisions Related to Serial (Repeat) Testing for the EUAs of 
Antigen IVDs.\6\
---------------------------------------------------------------------------

    \6\ FDA concluded revisions to the EUAs of the tests that are 
within the scope of the November 1, 2022, 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, including to 
revise the authorized use and to establish the additional condition 
set forth in the letter, as permitted by section 564(e) of the FD&C 
Act. The action is based on the available scientific evidence on the 
impact of serial testing on the performance of SARS-CoV-2 antigen 
tests. (Refer to: ``Performance of Screening for SARS-CoV-2 using 
Rapid Antigen Tests to Detect Incidence of Symptomatic and 
Asymptomatic SARS-CoV-2 Infection: findings from the Test Us at Home 
prospective cohort study'' at https://www.medrxiv.org/content/10.1101/2022.08.05.22278466v1.) The letter revised all current EUAs 
for antigen SARS-CoV-2 IVD devices as of November 1, 2022, by: (1) 
revising the authorized use to be for serial testing at least twice 
over 3 days for individuals with symptoms of COVID-19 and, for tests 
previously authorized for testing individuals without symptoms, 
revising the authorized use to be for serial testing at least thrice 
over 5 days for individuals without symptoms of COVID-19, (2) 
establishing a new condition of authorization regarding updating 
authorized labeling, and (3) eliminating a condition of 
authorization regarding evaluating clinical performance to support 
the serial screening claim.

    Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01180 Filed 1-20-23; 8:45 am]
BILLING CODE 4164-01-P


