[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]
[[Page 33685]]
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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).
[[Page 33686]]
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]
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