2024-02356. 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.

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 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.

Date: February 1, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.