Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 66711-66714 [2022-24072]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Notices]
[Pages 66711-66714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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 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 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.
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    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