Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation

Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

DATES:

The revocation of the Authorizations for the Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2 was effective as of February 24, 2026, InBios International, Inc.'s SCoV-2 Detect Neutralizing Ab ELISA was effective as of February 24, 2026, and Roche Diagnostics's Elecsys Anti-SARS-CoV-2 was effective as of March 2, 2026.

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 July 2, 2020, FDA issued the Authorization to Becton, Dickinson and Company (BD) for the BD Veritor System for Rapid Detection of SARS-CoV-2, 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 October 22, 2021, FDA issued the Authorization to InBios International, Inc. for the SCoV-2 Detect Neutralizing Ab ELISA, 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 May 2, 2020, FDA issued the Authorization to Roche Diagnostics for the Elecsys Anti-SARS-CoV-2, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (85 FR 42407), 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 January 29, 2026, Becton, Dickinson and Company requested the withdrawal of, and on February 24, 2026, FDA revoked, the Authorization for the Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2. BD notified FDA as the date of the letter there are no viable BD Veritor System for Rapid Detection of SARS-CoV-2 reagents remaining in distribution in the United States, and requested FDA withdraw the Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2. FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization given that BD has fully transitioned to the BD Veritor System for SARS-CoV-2 product cleared under K243872.

In a request received by FDA on February 16, 2026, InBios International, Inc. requested the revocation of, and on February 24, 2026, FDA revoked, the Authorization for the InBios International, Inc.'s SCoV-2 Detect Neutralizing Ab ELISA. FDA understands that as the date of the letter there are no viable SCoV-2 Detect Neutralizing Ab ELISA reagents remaining in distribution in the United States, and InBios International, Inc. requested FDA revoke its SCoV-2 Detect Neutralizing Ab ELISA. 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 6, 2026, Roche Diagnostics requested the revocation of, and on March 2, 2026, FDA revoked, the Authorization for the Roche Diagnostics's Elecsys Anti-SARS-CoV-2. FDA understands that as the date of the letter there are no viable Elecsys Anti-SARS-CoV-2 reagents remaining in distribution in the United States, and requested FDA revoke the Roche Diagnostics's Elecsys Anti-SARS-CoV-2. FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization given that Roche Diagnostics has fully transitioned to the Elecsys Anti-SARS-CoV-2 product cleared under K250768.

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 for Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc.'s SCoV-2 Detect Neutralizing Ab ELISA, and Roche Diagnostics's Elecsys Anti-SARS-CoV-2. 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.