Notice2023-05053
Revocation of Three 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
March 13, 2023
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 48 (Monday, March 13, 2023)</title>
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[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15412-15415]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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