In the April 22, 2016, Federal Register, FDA announced the issuance of an emergency use authorization ("EUA") for an in vitro diagnostic device for detection of the Zika virus. The EUA, requested by the U.S. Centers for Disease Control and Prevention, was issued in response to the Zika virus outbreak in the Americas. On February 26, 2016, HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the Zika virus. On the basis of such determination, HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of the Zika virus and/or diagnosis of Zika virus infection. The authorization was effective March 17, 2016.
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