[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Pages 8205-8208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02356]


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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 Device 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 Authorization (EUAs) (the 
Authorizations) issued to Southern California Permanente Medical Group, 
for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that

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includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel 
University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified 
Tetracore Assay. FDA revoked the Authorizations under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization 
holder. The revocations, which include an explanation of the reasons 
for each revocation, are reprinted at the end of this document.

DATES: The revocation of the Authorization for the Southern California 
Permanente Medical Group's Kaiser Permanente High Throughput SARS-CoV-2 
Assay, that includes the Kaiser Permanente Saliva Home Collection Kit, 
is effective as of September 29, 2023. The revocation of the 
Authorization for the Drexel University College of Medicine for the 
SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay is effective as of 
October 5, 2023.

ADDRESSES: Submit written requests for a single copy of the revocations 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, 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: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, radiological, or nuclear agent or 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 April 19, 2021, FDA 
issued the Authorization to Southern California Permanente Medical 
Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that 
includes the Kaiser Permanente Saliva Home Collection Kit, subject to 
the terms of the Authorization. Notice of the issuance of this 
Authorization was published in the Federal Register on July 23, 2021 
(86 FR 39040), as required by section 564(h)(1) of the FD&C Act.
    On April 28, 2023, FDA issued the Authorization to Drexel 
University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified 
Tetracore Assay, subject to the terms of the Authorization. Notice of 
the issuance of this Authorization was published in the Federal 
Register on January 25, 2024 (89 FR 4952), 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. Authorizations Revocation Requests

    In a request received by FDA on May 11, 2023, Southern California 
Permanente Medical Group requested the withdrawal of, and on September 
29, 2023, FDA revoked, the Authorization for the Southern California 
Permanente Medical Group's Kaiser Permanente High Throughput SARS-CoV-2 
Assay, that includes the Kaiser Permanente Saliva Home Collection Kit. 
Because Southern California Permanente Medical Group notified FDA that 
they have stopped distributing the Kaiser Permanente Saliva Home 
Collection Kit at the end of May 2023 and have also stopped receiving 
and processing the kits and requested FDA withdraw the Southern 
California Permanente Medical Group's Kaiser Permanente High Throughput 
SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home 
Collection Kit, 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 September 29, 2023, Drexel 
University College of Medicine requested the withdrawal of, and on 
October 5, 2023, FDA revoked, the Authorization for the Drexel 
University College of Medicine's SARS-CoV-2 DUCoM-PDL Modified 
Tetracore Assay. Because Drexel University College of Medicine notified 
FDA that they have discontinued the use of SARS-CoV-2 DUCoM-PDL 
Modified Tetracore Assay at Drexel University, Drexel Medicine 
Diagnostics and requested FDA withdraw the Drexel University College of 
Medicine's SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay, 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 EUA of Southern California Permanente Medical Group's 
Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the 
Kaiser Permanente Saliva Home Collection Kit, and Drexel University 
College of Medicine's SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. 
The revocation in its entirety follows and provide an explanation of 
the reasons for revocation, as required by section 564(h)(1) of the 
FD&C Act.
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[GRAPHIC] [TIFF OMITTED] TN06FE24.023


    Date: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02356 Filed 2-5-24; 8:45 am]
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