Notice2022-05892
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Abbott Diagnostics Scarborough, Inc. (Abbott) for the BinaxNOW COVID-19 Ag Card 2 Home Test. FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
Full Text
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<title>Federal Register, Volume 87 Issue 54 (Monday, March 21, 2022)</title>
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[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16005-16006]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05892]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0412]
Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Abbott Diagnostics Scarborough, Inc. (Abbott) for the
BinaxNOW COVID-19 Ag Card 2 Home Test. FDA revoked this Authorization
under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The
revocation, which includes an explanation of the reasons for
revocation, is reprinted in this document.
DATES: The Authorization for the BinaxNOW COVID-19 Ag Card 2 Home Test
is revoked as of February 24, 2022.
ADDRESSES: Submit a written request for a single copy of the revocation
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.
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, 240-402-8155 (this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological 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. On March 31, 2021, FDA issued an
EUA to Abbott for the BinaxNOW COVID-19 Ag Card 2 Home Test, subject to
the terms of the Authorization. Notice of the issuance of this
Authorization was published in the Federal Register on July 23, 2021
(86 FR 39040), as required by section 564(h)(1) of the FD&C Act.
Subsequent updates to the Authorization were made available on FDA's
website. The authorization of a device for emergency use under section
564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act,
be revoked when the criteria under section 564(c) of the FD&C Act for
issuance of such authorization are no longer met (section 564(g)(2)(B)
of the FD&C Act), or other circumstances make such revocation
appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. EUA Revocation Request
In a request received by FDA on February 21, 2022, Abbott requested
revocation of, and on February 24, 2022, FDA revoked, the Authorization
for the BinaxNOW COVID-19 Ag Card 2 Home Test. Because Abbott notified
FDA that the EUA for BinaxNOW COVID-19 Ag Card 2 Home Test is no longer
required and requested FDA revoke the EUA for the BinaxNOW COVID-19 Ag
Card 2 Home Test, FDA has determined that it is appropriate to protect
the public health or safety to revoke this Authorization.
III. Electronic Access
An electronic version of this document and the full text of the
revocation is available on the internet at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
IV. The Revocation
Having concluded that the criteria for revocation of the
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of Abbott for the BinaxNOW COVID-19 Ag Card 2 Home
Test. The revocation in its entirety follows and provides an
explanation of the reasons for revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
[[Page 16006]]
[GRAPHIC] [TIFF OMITTED] TN21MR22.036
Dated: March 15, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-05892 Filed 3-18-22; 8:45 am]
BILLING CODE 4164-01-C
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