Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus 

On February 26, 2016, HHS Secretary Sylvia M. Burwell determined that there is a significant potential for a public health emergency that could affect the health and security of  U.S. citizens living abroad and that involves Zika virus. Based on that determination, Secretary Burwell has declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

View a copy of the formal notice published in the March 2, 2016, Federal Register.