Document ID: FDA-2022-N-0150-0006
Agency: fda
Document Type: Notice
Title: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-09-09T04:00Z

[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55435-55438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19491]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]

Revocation of Two 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 Becton, Dickinson and Company (BD) for the BD 
SARS-CoV-2/Flu for BD MAX System, and Talis Biomedical Corporation 
(Talis) for the Talis One COVID-19 Test System. 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 BD SARS-CoV-2/Flu for BD MAX System is 
revoked as of August 1, 2022. The Authorization for the Talis One 
COVID-19 Test System is revoked as of August 23, 2022.

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 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 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

[[Page 55436]]

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 February 10, 
2021, FDA issued an EUA to BD for the BD SARS-CoV-2/Flu for BD MAX 
System, subject to the terms of the Authorization. Notice of the 
issuance of this Authorization was published in the Federal Register on 
April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the 
FD&C Act. On November 5, 2021, FDA issued an EUA to Talis for the Talis 
One COVID-19 Test System, subject to the terms of the Authorization. 
Notice of the issuance of this Authorization was published in the 
Federal Register on March 22, 2022 (87 FR 16196), as required by 
section 564(h)(1) of the FD&C Act. Subsequent updates 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

    In a request received by FDA on July 26, 2022, BD requested 
withdrawal of, and effective August 1, 2022, FDA revoked, the 
Authorization for the BD SARS-CoV-2/Flu for BD MAX System. Because BD 
notified FDA that BD has discontinued the sale of the BD SARS-CoV-2/Flu 
for BD MAX System and requested FDA to withdraw the authorization of 
the BD SARS-CoV-2/Flu for BD MAX System, FDA has determined that it is 
appropriate to protect the public health or safety to revoke this 
Authorization.
    In a request received by FDA on August 12, 2022, Talis requested 
revocation of, and on August 23, 2022, FDA revoked, the Authorization 
for the Talis One COVID-19 Test System. Because Talis notified FDA that 
Talis has not commercially distributed the authorized product in the 
United States and requested FDA revoke the authorization of the Talis 
One COVID-19 Test System, 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 
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 EUA of BD for the BD SARS-CoV-2/Flu for BD MAX System 
and of Talis for the Talis One COVID-19 Test System. 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: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19491 Filed 9-8-22; 8:45 am]
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