Notice2022-19491
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices 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
September 9, 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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 174 (Friday, September 9, 2022)</title>
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[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55435-55438]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
BILLING CODE 4164-01-P
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[GRAPHIC] [TIFF OMITTED] TN09SE22.044
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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]
BILLING CODE 4164-01-C
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