Document ID: FDA-2022-N-0150-0003
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: 2022-05-09T04:00Z

[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27646-27650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 27647]]

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 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 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.
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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]
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