2023-03373: Termination of Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Enterovirus D68
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The Food and Drug Administration (FDA) is announcing the termination of the May 12, 2015, Emergency Use Authorization (EUA) (authorization) issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the Centers for Disease Control and Prevention's (CDC) Enterovirus D68 (EV-D68) 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT- PCR) (CDC EV-D68 EUA). Issuance of the CDC EV-D68 EUA was supported by former Secretary of Health and Human Services (HHS) Sylvia M. Burwell's February 6, 2015, declaration that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68, pursuant to the FD&C Act. On February 6, 2023, the Secretary of HHS terminated the February 6, 2015, declaration, effective February 20, 2023, an action that automatically terminated any EUAs issued by the FDA pursuant to the declaration, in this case, the CDC EV-D68 EUA.
The agency’s own summary, as published.
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