Document ID: FDA-2021-N-0412-0003
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-03-21T04:00Z

[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16005-16006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov/.

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.
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[[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]
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