2023-02074. Revocation of Four 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 Mammoth Biosciences, Inc. for the SARS-CoV-2 DETECTR Reagent Kit and DETECTR BOOST SARS-CoV-2 Reagent Kit, to the University of Arizona Genetics Core for Clinical Services for the COVID-19 ELISA pan-Ig Antibody Test, and to ChromaCode, Inc. for the HDPCR SARS-CoV-2 Assay. 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 SARS-CoV-2 DETECTR Reagent Kit and DETECTR BOOST SARS-CoV-2 Reagent Kit are revoked as of December 15, 2022. The Authorization for the COVID-19 ELISA pan-Ig Antibody Test is revoked as of December 16, 2022. The Authorization for the HDPCR SARS-CoV-2 Assay is revoked as of January 3, 2023.

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 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) 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, 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 31, 2020, FDA issued an EUA to Mammoth Biosciences, Inc. for the SARS-CoV-2 DETECTR Reagent Kit, 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 January 21, 2022, FDA issued an EUA to Mammoth Biosciences, Inc. for the DETECTR BOOST SARS-CoV-2 Reagent Kit, 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 16196), as required by section 564(h)(1) of the FD&C Act. On August 31, 2020, FDA issued an EUA to the University of Arizona Genetics Core for Clinical Services for the COVID-19 ELISA pan-Ig Antibody Test, 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 June 9, 2020, FDA issued an EUA to ChromaCode, Inc. for the HDPCR 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. Subsequent revisions 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

On October 20, 2022, FDA received requests from Mammoth Biosciences, Inc. for the withdrawal of, and on December 15, 2022, FDA revoked, the Authorizations for the SARS-CoV-2 DETECTR Reagent Kit and DETECTR BOOST SARS-CoV-2 Reagent Kit. Because Mammoth Biosciences, Inc. requested FDA withdraw the EUAs for the SARS-CoV-2 DETECTR Reagent Kit and DETECTR BOOST SARS-CoV-2 Reagent Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke these Authorizations. On December 14, 2022, FDA received a request from the University of Arizona Genetics Core for Clinical Services for the withdrawal of, and on December 16, 2022, FDA revoked, the Authorization for the COVID-19 ELISA pan-Ig Antibody Test. Because the University of Arizona Genetics Core for Clinical Services requested FDA withdraw the EUA for the COVID-19 ELISA pan-Ig Antibody Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 2, 2022, FDA received a request from ChromaCode, Inc., for the revocation of, and on January 3, 2023, FDA revoked, the Authorization for the HDPCR SARS-CoV-2 Assay. Because ChromaCode, Inc. requested FDA revoke the EUA for the HDPCR SARS-CoV-2 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 EUAs for Mammoth Biosciences, Inc.'s SARS-CoV-2 DETECTR Reagent Kit and DETECTR BOOST SARS-CoV-2 Reagent Kit, the University of Arizona Genetics Core for Clinical Services's COVID-19 ELISA pan-Ig Antibody Test, and ChromaCode, Inc.'s HDPCR SARS-CoV-2 Assay. 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: January 26, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.