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Medical Devices / Regulatory Affairs

FDA Issues Emergency Use Authorization for Ebola Virus Diagnostic

Feb. 14, 2019

The FDA issued an Emergency Use Authorization to Chembio Diagnostic Systems for an in vitro diagnostic device for detection of Ebola virus.

HHS declared on Aug. 5, 2014 that the circumstances justify the authorization of emergency use of IVDs for detection of the virus.

The declaration responded to the Ebola outbreak in the Democratic Republic of the Congo and the Department of Homeland Security’s determination that the virus presents a material threat against the U.S. population sufficient to affect national security.

Conditions for an EUA include that there is no available alternative to the product for diagnosing the disease.

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