Federal Register #2026-12906

FDA Revokes EUAs for Three COVID-19 Diagnostic Devices from BD, InBios, and Roche

This notice announces the revocation of Emergency Use Authorizations (EUAs) for three COVID-19 diagnostic devices by the Food and Drug Administration (FDA), part of the Department of Health and Human Services. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Becton, Dickinson and Company (BD) - InBios International, Inc. - Roche Diagnostics - Products/Devices Affected: - BD Veritor System for Rapid Detection of SARS-CoV-2 (BD) - SCoV-2 Detect Neutralizing Ab ELISA (InBios International) - Elecsys Anti-SARS-CoV-2 (Roche Diagnostics) - Notable Requirements/Details: - Revocations were requested by the authorization holders (the OEMs) - No viable reagents for these devices remain in distribution in the United States - BD and Roche Diagnostics have transitioned to new products cleared under updated regulatory authorizations - This is a regulatory action, not a procurement or contract opportunity

Description

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) issued to Becton, Dickinson and Company for the BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc. for the SCoV-2 Detect Neutralizing Ab ELISA, and Roche Diagnostics for the Elecsys Anti-SARS-CoV-2. These revocations were requested by the authorization holders and are made under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations are effective as of February 24, 2026, for BD and InBios, and March 2, 2026, for Roche. The notice provides reasons for each revocation and access to related documents and images.

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