2023-09879. 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.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Thermo Fisher Scientific Inc., for the OmniPATH COVID–19 Total Antibody ELISA Test; Detect, Inc., for the Detect Covid–19 Test; and Cepheid, for the Xpert Xpress SARS–CoV–2/Flu/RSV. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.

DATES:

The Authorization for the Thermo Fisher Scientific Inc.'s OmniPATH COVID–19 Total Antibody ELISA Test is revoked as of April 13, 2023. The Authorization for the Detect, Inc.'s Detect Covid–19 Test is revoked as of April 14, 2023. The Authorization for the Cepheid's Xpert Xpress SARS–CoV–2/Flu/RSV is revoked as of April 17, 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 October 2, 2020, FDA issued the Authorization to Thermo Fisher Scientific Inc., for the OmniPATH COVID–19 Total Antibody ELISA 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. On October 28, 2021, FDA issued the Authorization to Detect, Inc., for the Detect Covid–19 Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on March 22, 2022 (87 FR 16198), as required by section 564(h)(1) of the FD&C Act. On September 24, 2020, FDA issued the Authorization to Cepheid, for the Xpert Xpress SARS–CoV–2/Flu/RSV, 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 21751), 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. Authorization Revocation Requests

In a request received by FDA on April 10, 2023, Thermo Fisher Scientific Inc., requested the withdrawal of, and on April 13, 2023, FDA revoked, the Authorization for the Thermo Fisher Scientific Inc.'s OmniPATH COVID–19 Total Antibody ELISA Test. Because Thermo Fisher Scientific Inc., notified FDA that it is no longer manufacturing or producing the OmniPATH COVID–19 Total Antibody ELISA Test and requested FDA withdraw the Thermo Fisher Scientific Inc.'s, OmniPATH COVID–19 Total Antibody ELISA Test, 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 March 16, 2023, Detect, Inc., requested revocation of, and on April 14, 2023, FDA revoked, the Authorization for the Detect, Inc.'s Detect Covid–19 Test. Because Detect, Inc., indicated to FDA that as of February 1, 2023, there are no viable/nonexpired Detect Covid–19 Tests in distribution in the United States and requested FDA revoke the Authorization for the Detect Covid–19 Test, 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 March 7, 2023, Cepheid, requested revocation of, and on April 17, 2023, FDA revoked, the Authorization for the Cepheid's Xpert Xpress SARS–CoV–2/Flu/RSV. Because Cepheid, indicated to FDA that they have stopped sales of the authorized product and requested FDA revoke the Authorization for the Cepheid's Xpert Xpress SARS–CoV–2/Flu/RSV, 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 Thermo Fisher Scientific Inc.'s OmniPATH COVID–19 Total Antibody ELISA Test; Detect, Inc's Detect Covid–19 Test; and of Cepheid's Xpert Xpress SARS–CoV–2/Flu/RSV. 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.

Dated: May 4, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.