In the March 26, 2016, Federal Register, FDA announced the issuance of an Emergency Use Authorization ("EUA") (the "Authorization") for an in vitro diagnostic device for diagnosis of Zika virus infection in response to the Zika virus outbreak in the Americas. FDA issued the Authorization under the FDCA in response to a request by the U.S. Centers for Disease Control and Prevention. Among other things, the Authorization contains conditions on the emergency use of the authorized device. On February 26, 2016, the Department of Health and Human Services ("HHS") determined there is a significant potential for a public health emergency with significant potential to affect national security or the health and security of U.S. citizens living abroad involving Zika virus. On the basis of such determination, HHS declared that circumstances exist justifying the authorization of emergency use of the in vitro diagnostic tests. The Authorization was effective February 26, 2016.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
