Authorization of Medical Products for Use Emergencies

This Information Collection Request (ICR) collects information from manufacturers and public health authorities applicable to the authorization of the emergency use of certain medical products during a declared emergency. Respondents submit information as recommended in Food and Drug Administration (FDA or Agency) guidance, including a description of the medical product and the intended use, reports after administration of such a product, and requests for extension of the expiration date of eligible products.

The latest form for Authorization of Medical Products for Use Emergencies expires 2022-08-31 and can be found here.

Requests to Issue an EUA or a Substantive Amendment to an Existing EUA

Federal Enterprise Architecture: Health - Consumer Health and Safety