Authorization of Medical Products for Use Emergencies

OMB 0910-0595

OMB 0910-0595

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.

OMB Details

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

Federal Enterprise Architecture: Health - Consumer Health and Safety

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