Notice2022-28496
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
January 3, 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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 1 (Tuesday, January 3, 2023)</title>
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[Federal Register Volume 88, Number 1 (Tuesday, January 3, 2023)]
[Notices]
[Pages 75-79]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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