Notice2022-24072
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
November 4, 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 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute (Cleveland Clinic) for the Cleveland Clinic SARS-CoV-2 Assay and SelfCheck COVID-19 TaqPath Multiplex PCR. 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 213 (Friday, November 4, 2022)</title>
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[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Notices]
[Pages 66711-66714]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24072]
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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 Cleveland Clinic Robert J. Tomsich Pathology
and Laboratory Medicine Institute (Cleveland Clinic) for the Cleveland
Clinic SARS-CoV-2 Assay and SelfCheck COVID-19 TaqPath Multiplex PCR.
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 Authorizations for the Cleveland Clinic SARS-CoV-2 Assay and
SelfCheck COVID-19 TaqPath Multiplex PCR are revoked as of October 19,
2022.
[[Page 66712]]
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, 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) 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 August 3, 2020, FDA issued an EUA to Cleveland Clinic
for the Cleveland Clinic SARS-CoV-2 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 August 9, 2021,
FDA issued an EUA to Cleveland Clinic for the SelfCheck COVID-19
TaqPath Multiplex PCR, subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on October 28, 2021 (86 FR 59738), 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 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 October 7, 2022, Cleveland Clinic
requested revocation of, and on October 19, 2022, FDA revoked, the
Authorization for the Cleveland Clinic SARS-CoV-2 Assay. Because
Cleveland Clinic notified FDA that it is no longer using the Cleveland
Clinic SARS-CoV-2 Assay and does not plan to use it in the future and
requested FDA revoke the EUA for the Cleveland Clinic SARS-CoV-2 Assay,
FDA has determined that it is appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on October 7, 2022, Cleveland Clinic
requested revocation of, and on October 19, 2022, FDA revoked, the
Authorization for the SelfCheck COVID-19 TaqPath Multiplex PCR. Because
Cleveland Clinic notified FDA that it is no longer using the SelfCheck
COVID-19 TaqPath Multiplex PCR and does not plan to use it in the
future and requested FDA revoke the EUA for the SelfCheck COVID-19
TaqPath Multiplex PCR, FDA has 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 EUAs of Cleveland Clinic for the Cleveland Clinic SARS-
CoV-2 Assay and SelfCheck COVID-19 TaqPath Multiplex PCR. 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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[GRAPHIC] [TIFF OMITTED] TN04NO22.074
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[GRAPHIC] [TIFF OMITTED] TN04NO22.075
Dated: October 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24072 Filed 11-3-22; 8:45 am]
BILLING CODE 4164-01-C
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