[Federal Register Volume 85, Number 106 (Tuesday, June 2, 2020)]
[Notices]
[Pages 33685-33686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11898]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1338]


Process for Publishing Emergency Use Authorizations for Medical 
Devices During Coronavirus Disease 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
process for publishing FDA Emergency Use Authorizations (EUAs) for 
medical devices related to the Coronavirus Disease 2019 (COVID-19) 
public health emergency. FDA believes that this process will allow the 
Agency to rapidly publish EUAs that have been issued for medical 
devices under the Federal Food, Drug, and Cosmetic Act.

DATES: This process is effective June 2, 2020.

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 Authorizations.

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 Federal Food, Drug, and Cosmetic Act (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 
biological, chemical, radiological or nuclear agent or agents when 
there are no adequate, approved, and available alternatives and other 
criteria are met.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of Health and Human Services (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, United States Code, of attack with (i) a biological, chemical, 
radiological, or nuclear agent or agents; or (ii) 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 under 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. 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.
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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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    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. Additionally, under this provision, the 
Secretary shall make any revisions to an authorization under section 
564 of the FD&C Act available on FDA's website.

II. Medical Devices for Which the Secretary Has Declared That 
Circumstances Exist Justifying Their Emergency Use

    On February 4, 2020, the Secretary of HHS determined 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 SARS-CoV-2. Pursuant to this 
determination, the Secretary has made the following declarations that 
circumstances exist justifying the authorization of emergency use of 
the following products:
     On February 4, 2020, under section 564(b)(1) of the FD&C 
Act, the Secretary of HHS declared that circumstances exist justifying 
the authorization of emergency use of in vitro diagnostics for 
detection and/or diagnosis of the virus (SARS-CoV-2), subject to the 
terms of any authorization issued under section 564 of the FD&C Act. 
Notice of the determination and declaration of the Secretary was 
published in the Federal Register on February 7, 2020 (85 FR 7316).
     On March 2, 2020, under section 564(b)(1) of the FD&C Act, 
the Secretary of HHS declared that circumstances exist justifying the 
authorization of emergency use of personal respiratory protective 
devices during the COVID-19 outbreak, subject to the terms of any 
authorization issued under section 564 of the FD&C Act. Notice of the 
declaration of the Secretary was published in the Federal Register on 
March 10, 2020 (85 FR 13907).
     On March 24, 2020, under section 564(b)(1) of the FD&C 
Act, the Secretary of HHS declared that circumstances exist justifying 
the authorization of emergency use of medical devices, including 
alternative products use as medical devices, due to shortages during 
the COVID-19 outbreak, subject to the terms of any authorization issued 
under section 564 of the FD&C Act. Notice of the declaration of the 
Secretary was published in the Federal Register on March 27, 2020 (85 
FR 17335).

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III. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. Process for Publishing EUAs for Medical Devices During COVID-19

    To facilitate publication of each EUA, and each termination or 
revocation of an EUA under section 564, in accordance with section 
564(h)(1) of the FD&C Act, the Agency intends to use the following 
process:
     Rather than publishing a separate Notice of Availability 
(NOA) for each COVID-19 related EUA for a medical device, FDA intends 
to publish periodically a consolidated NOA. This periodic NOA will 
announce the availability of all the COVID-19 related EUAs for medical 
devices that issued during the relevant period. The consolidated NOA 
will provide instructions to the public on how to view the EUAs, and 
instructions for persons interested in obtaining a copy of the COVID-19 
related EUAs.
     COVID-19 related EUAs for medical devices will be 
accessible on the internet at 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.
     COVID-19 related EUAs for medical devices are also 
currently accessible on the internet from the FDA web page entitled 
``Emergency Use Authorizations,'' available at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

    Dated: May 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11898 Filed 6-1-20; 8:45 am]
 BILLING CODE 4164-01-P