Document ID: FDA-2021-N-0973-0005
Agency: fda
Document Type: Notice
Title: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis
of COVID–19; Availability
Posted Date: 2023-03-13T04:00Z

[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15412-15415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0973]

Revocation of Three Authorizations of Emergency Use of In Vitro 
Diagnostic Devices 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 Authorizations (EUAs) (the 
Authorizations) issued to Abbott Diagnostics Scarborough, Inc. (Abbott) 
for the BinaxNOW COVID-19 Ag 2 Card, and Standard BioTools, Inc. 
(Standard) for the Advanta Dx SARS-CoV-2 RT-PCR Assay and Advanta Dx 
COVID-19 EASE Assay. FDA revoked these Authorizations under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include 
an explanation of the reasons for each revocation, are reprinted in 
this document.

DATES: The Authorization for the BinaxNOW COVID-19 Ag 2 Card is revoked 
as of January 31, 2023. The Authorizations for the Advanta Dx SARS-CoV-
2 RT-PCR Assay and Advanta Dx COVID-19 EASE Assay are revoked as of 
February 1, 2023.

ADDRESSES: Submit written requests for a single copy of the revocations 
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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer 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 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 2 Card, 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. On August 25, 2020, FDA 
issued an EUA to Standard (then known as Fluidigm Corp.) for the 
Advanta Dx SARS-CoV-2 RT-PCR Assay, subject to the terms of the 
Authorization. Notice of the issuance of this Authorization was 
published in the Federal Register on November 20, 2020 (85 FR 74346), 
as required by section 564(h)(1) of the FD&C Act. On February 7, 2022, 
FDA issued an EUA to Standard (then known as Fluidigm Corp.) for the 
Advanta Dx COVID-19 EASE Assay, subject to the terms of the 
Authorization. Notice of the issuance of this Authorization was 
published in the Federal Register on July 22, 2022 (87 FR 43877), as 
required by section 564(h)(1) of the FD&C Act. Subsequent revisions to 
the Authorizations 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 Requests

    On January 20, 2023, FDA received a request from Abbott for the 
revocation of, and on January 31, 2023, FDA revoked, the Authorization 
for the BinaxNOW COVID-19 Ag 2 Card. Because Abbott requested FDA 
revoke the EUA for the BinaxNOW COVID-19 Ag 2 Card, FDA has determined 
that it is appropriate to protect the public health or safety to revoke 
this

[[Page 15413]]

Authorization. On January 30, 2023, FDA received a request from 
Standard for the withdrawal of, and on February 1, 2023, FDA revoked, 
the Authorizations for the Advanta Dx SARS-CoV-2 RT-PCR Assay and 
Advanta Dx COVID-19 EASE Assay. Because Standard requested FDA withdraw 
the EUAs for the Advanta Dx SARS-CoV-2 RT-PCR Assay and Advanta Dx 
COVID-19 EASE Assay, FDA has determined that it is appropriate to 
protect the public health or safety to revoke these Authorizations.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the 
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUAs for Abbott's BinaxNOW COVID-19 Ag 2 Card, and 
Standard's Advanta Dx SARS-CoV-2 RT-PCR Assay and Advanta Dx COVID-19 
EASE Assay. The revocations in their entirety follow and provide an 
explanation of the reasons for each revocation, as required by section 
564(h)(1) of the FD&C Act.
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    Dated: March 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05053 Filed 3-10-23; 8:45 am]
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