Authorization of Emergency Use of an In Vitro Diagnostic for Detection of the Novel Avian Influenza A(H7N9) Virus; Availability

الملخص

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 the novel avian influenza A(H7N9) virus. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic (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 that involves the novel avian influenza A(H7N9) virus. 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 the novel avian influenza A(H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuan