Notice2022-09887
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
May 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 Bio-Rad Laboratories, Inc., for the Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit and to Applied DNA Sciences, Inc., for the Linea COVID-19 Assay Kit. 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 89 (Monday, May 9, 2022)</title>
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[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27646-27650]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09887]
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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 Bio-Rad Laboratories, Inc., for the Bio-Rad
Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit and to Applied DNA
Sciences, Inc., for the Linea COVID-19 Assay Kit. 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 Bio-Rad Reliance SARS-CoV-2/FluA/FluB
RT-PCR Assay Kit is revoked as of April 15, 2022. The Authorization for
the Linea COVID-19 Assay Kit is revoked as of April 20, 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, 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 February 11, 2021, FDA issued
an EUA to Bio-Rad Laboratories, Inc., for the Bio-Rad Reliance SARS-
CoV-2/FluA/FluB RT-PCR Assay Kit, 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 May 13, 2020, FDA
issued an EUA to Applied DNA Sciences, Inc. for the Linea COVID-19
Assay Kit, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 14, 2020 (85 FR 42407), 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
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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 March 17, 2022, Bio-Rad
Laboratories, Inc., requested revocation of, and on April 15, 2022, FDA
revoked, the Authorization for the Bio-Rad Reliance SARS-CoV-2/FluA/
FluB RT-PCR Assay Kit. Because Bio-Rad Laboratories, Inc. notified FDA
that it has ceased U.S. distribution of the Reliance SARS-CoV-2/FluA/
FluB RT-PCR Assay Kit, has discontinued the assay, and requested FDA
revoke the EUA for the Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit,
FDA determined that it is appropriate to protect the public health or
safety to revoke this Authorization.
In a request received by FDA on April 7, 2022, Applied DNA
Sciences, Inc., requested revocation of, and on April 20, 2022, FDA
revoked, the Authorization for the Linea COVID-19 Assay Kit. Because
Applied DNA Sciences, Inc. notified FDA that it has decided to
discontinue distribution of the Linea COVID-19 Assay Kit and requested
FDA withdraw the EUA for the Linea COVID-19 Assay Kit, FDA 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 Bio-Rad Laboratories, Inc., for the Bio-Rad
Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit, and Applied DNA
Sciences, Inc., for the Linea COVID-19 Assay Kit. 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: May 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09887 Filed 5-6-22; 8:45 am]
BILLING CODE 4164-01-C
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