FDA Authorizes Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus

FDA issued this emergency use authorization under the Federal Food, Drug, and Cosmetic Act as requested by Viracor-IBT Laboratories, Inc. for in vitro diagnostic testing.

The authorization follows the February 26, determination by the Secretary of Health and Human Services (HHS) 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 Zika virus.

The authorization is effective as of July 19, 2016. — Cynthia Jessup