In the April 22, 2016, Federal Register, FDA announced the issuance of an EUA for an in vitro diagnostic device for detection of the Ebola Zaire virus. The EUA, requested by OraSure Technologies, Inc., was issued in response to the Ebola virus outbreak in West Africa. On September 22, 2006, the Department of Homeland Security had determined that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus. The authorization was effective March 4, 2016.
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