Document ID: FDA-2021-N-0973-0004
Agency: fda
Document Type: Notice
Title: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2023-01-03T05:00Z

[Federal Register Volume 88, Number 1 (Tuesday, January 3, 2023)]
[Notices]
[Pages 75-79]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28496]

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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 the University of Texas MD Anderson Cancer 
Center, Molecular Diagnostics Laboratory (MD Anderson) for the MD 
Anderson High-throughput SARS-CoV-2 RT-PCR Assay, and Visby Medical, 
Inc. for the Visby Medical COVID-19 and Visby Medical COVID-19 Point of 
Care Test. 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 MD Anderson High-throughput SARS-CoV-2 
RT-PCR Assay is revoked as of November 30, 2022. The Authorizations for 
the Visby Medical COVID-19 and Visby Medical COVID-19 Point of Care 
Test are revoked as of December 2, 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 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 June 24, 2020, FDA issued an 
EUA to MD Anderson for the MD Anderson High-throughput 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 September 16, 2020, FDA issued an EUA to Visby 
Medical, Inc. for the Visby Medical COVID-19, 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 February 8, 2021, FDA 
issued an EUA to Visby Medical, Inc. for the Visby Medical COVID-19 
Point of Care Test, 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. 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

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the public health or safety (section 564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Requests

    On November 18, 2022, FDA received a request from MD Anderson for 
the withdrawal of, and on November 30, 2022, FDA revoked, the 
Authorization for the MD Anderson High-throughput SARS-CoV-2 RT-PCR 
Assay. Because MD Anderson requested FDA withdraw the EUA for the MD 
Anderson High-throughput SARS-CoV-2 RT-PCR Assay, FDA has determined 
that it is appropriate to protect the public health or safety to revoke 
this Authorization. On November 29, 2022, FDA received a request from 
Visby Medical, Inc. for the closure of, and on December 2, 2022, FDA 
revoked, the Authorizations for the Visby Medical COVID-19 and Visby 
Medical COVID-19 Point of Care Test. Because Visby Medical, Inc. 
requested FDA close the EUAs for the Visby Medical COVID-19 and Visby 
Medical COVID-19 Point of Care Test, 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 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 EUAs for MD Anderson's MD Anderson High-throughput 
SARS-CoV-2 RT-PCR Assay and for Visby Medical, Inc.'s Visby Medical 
COVID-19 and Visby Medical COVID-19 Point of Care Test. 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: December 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28496 Filed 12-30-22; 8:45 am]
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