Guidance; Emergency Use Authorization of Medical Products; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Emergency Use Authorization of Medical Products." The guidance explains FDA's policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. This guidance finalizes the draft guidance published in the Federal Register of July 5, 2005 (70 FR 38689).