What is an emergency use authorization (EUA)?
The U.S. Food and Drug Administration has issued emergency use authorizations to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the 2009 H1N1 influenza virus under certain circumstances. There are no FDA cleared or approved tests for the identification of the 2009 H1N1 influenza virus. The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met.
