[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24996-24997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1357]


Authorization of Emergency Use of a Medical Device 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 an Emergency Use Authorization (EUA) (the 
Authorization) for a medical device related to the Coronavirus Disease 
2019 (COVID-19) public health emergency. FDA has issued the 
Authorization indicated in this document under the Federal Food, Drug, 
and Cosmetic Act (FD&C Act). This Authorization contains, among other 
things, conditions on the emergency use of the authorized product. 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. The 
Authorization, which includes an explanation of the reasons for 
issuance, is specified in this document, and can be accessed on FDA's 
website from the links indicated.

DATES: The Authorization is effective on the 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: 

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,

[[Page 24997]]

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 
Authorization is 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 Authorization

    Having concluded that the criteria for the issuance of the 
following Authorization under section 564(c) of the FD&C Act are met, 
FDA has authorized the emergency use of the following product for 
diagnosing, treating, or preventing COVID-19 subject to the terms of 
each Authorization. The Authorization in its 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 list includes the Authorization issued on March 24, 2023, and we 
have included an explanation of the reasons for the issuance, as 
required by section 564(h)(1) of the FD&C Act. In addition, any 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 Authorization for a 
molecular diagnostic and antigen test for COVID-19, excluding 
multianalyte tests: \3\
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    \3\ 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, 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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     BioSynchronicity Corporation's C-Sync COVID-19 Antigen 
Test, issued March 24, 2023.

    Dated: April 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08641 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P


