Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus; Availability

摘要

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic (the FD&C) Act, as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the 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 MERS-CoV. On the basis of such determination, the Secretary also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of MERS-CoV subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the re