2024-05980. Revocation of Six 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 Authorizations (EUAs) (the Authorizations) issued to Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID–19 Pooling Kit; Bio-Rad Laboratories, Inc., for the Reliance SARS–CoV–2 RT–PCR Assay Kit; Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit; bioMérieux SA for the VIDAS SARS–CoV–2 IgM kit; bioMérieux SA for the VIDAS SARS–CoV–2 IgG kit; and Luminex Corp. for the xMAP SARS–CoV–2 Multi-Antigen IgG 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 Authorization for the Life Technologies Corp.'s (a legal entity of Thermo Fisher Scientific, Inc.) TaqPath COVID–19 Pooling Kit is revoked as of January 16, 2024. The Authorization for the Bio-Rad Laboratories, Inc.'s Reliance SARS–CoV–2 RT–PCR Assay Kit is revoked as of January 16, 2024. The Authorization for the Revvity, Inc.'s (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)) PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit is revoked as of January 30, 2024. The Authorization for the bioMérieux SA's VIDAS SARS–CoV–2 IgM kit is revoked as of January 31, 2024. The Authorization for the bioMérieux SA's VIDAS SARS–CoV–2 IgG kit is revoked as of January 31, 2024. The Authorization for the Luminex Corp.'s xMAP SARS–CoV–2 Multi-Antigen IgG Assay is revoked as of February 22, 2024.

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 May 25, 2021, FDA issued the Authorization to Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID–19 Pooling 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 at 39043), as required by section 564(h)(1) of the FD&C Act.

On January 15, 2021, FDA issued the Authorization to Bio-Rad Laboratories, Inc., for the Reliance SARS–CoV–2 RT–PCR Assay Kit, 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 21549 at 21751), as required by section 564(h)(1) of the FD&C Act.

On April 12, 2021, FDA issued the Authorization to PerkinElmer Genomics, (Revvity, Inc. (Revvity Omics, a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)) for the PerkinElmer SARS–CoV–2 RT–qPCR Reagent 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 at 39042), as required by section 564(h)(1) of the FD&C Act.

On August 6, 2020, FDA issued the Authorization to bioMérieux SA for the VIDAS SARS–CoV–2 IgM 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 at 74350), as required by section 564(h)(1) of the FD&C Act.

On August 6, 2020, FDA issued the Authorization to bioMérieux SA for the VIDAS SARS–CoV–2 IgG 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 at 74350), as required by section 564(h)(1) of the FD&C Act.

On July 16, 2020, FDA issued the Authorization to Luminex Corp. for the xMAP SARS–CoV–2 Multi-Antigen IgG 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 at 74350), 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 November 13, 2023, Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), requested the revocation of, and on January 16, 2024, FDA revoked, the Authorization for the Life Technologies Corp.'s (a legal entity of Thermo Fisher Scientific, Inc.) TaqPath COVID–19 Pooling Kit. Because Life Technologies Corp. notified FDA that they are no longer commercially supporting the TaqPath COVID–19 Pooling Kit and requested FDA revoke the Authorization for Life Technologies Corp.'s TaqPath COVID–19 Pooling 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 January 7, 2024, Bio-Rad Laboratories, Inc., requested the revocation of, and on January 16, 2024, FDA revoked, the Authorization for Bio-Rad Laboratories, Inc.'s Reliance SARS–CoV–2 RT–PCR Assay Kit. Because Bio-Rad Laboratories, Inc. notified FDA that they have ceased U.S. distribution of the Bio-Rad Reliance SARS–CoV–2 RT–PCR Assay Kit and requested FDA revoke the Authorization for Bio-Rad Laboratories, Inc.'s Reliance SARS–CoV–2 RT–PCR Assay 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 January 19, 2024, Revvity, Inc. (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), requested the revocation of, and on January 30, 2024, FDA revoked, the Authorization for the Revvity, Inc.'s PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit. Because Revvity, Inc. notified FDA that they have discontinued use of the PerkinElmer SARS–CoV–2 RT–qPCR Reagent Kit at the Revvity Omics laboratory, and requested FDA revoke the Authorization for Revvity, Inc.'s PerkinElmer SARS–CoV–2 RT–qPCR Reagent 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 January 22, 2024, bioMérieux SA, requested the revocation of, and on January 31, 2024, FDA revoked, the Authorization for the bioMérieux SA's VIDAS SARS–CoV–2 IgM kit. Because bioMérieux SA notified FDA that they will no longer commercially support the authorized product, and requested FDA revoke the Authorization for bioMérieux SA's VIDAS SARS–CoV–2 IgM 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 January 22, 2024, bioMérieux SA, requested the revocation of, and on January 31, 2024, FDA revoked, the Authorization for the bioMérieux SA's VIDAS SARS–CoV–2 IgG kit. Because bioMérieux SA notified FDA that they will no longer commercially support the authorized product, and requested FDA revoke the Authorization for bioMérieux SA's VIDAS SARS–CoV–2 IgG 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 February 19, 2024, Luminex Corp., requested the withdrawal of, and on February 22, 2024, FDA revoked, the Authorization for the Luminex Corp.'s xMAP SARS–CoV–2 Multi-Antigen IgG Assay. Because Luminex Corp. notified FDA that they have discontinued the manufacture of the authorized product, and requested FDA revoke the Authorization for Luminex Corp.'s xMAP SARS–CoV–2 Multi-Antigen IgG 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 Life Technologies Corp.'s (a legal entity of Thermo Fisher Scientific, Inc.) TaqPath COVID–19 Pooling Kit, Bio-Rad Laboratories, Inc.'s Reliance SARS–CoV–2 RT–PCR Assay Kit, Revvity, Inc.'s (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)) PerkinElmer SARS–CoV–2 RT-qPCR Reagent Kit, bioMérieux SA's VIDAS SARS–CoV–2 IgM kit, bioMérieux SA's VIDAS SARS–CoV–2 IgG kit, and Luminex Corp.'s xMAP SARS–CoV–2 Multi-Antigen IgG Assay. The revocations in their entirety follow and provide an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.

Dated: March 15, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.