Zdrowie i gospodarka · 19/04/2010

FDA Announces Authorization of Emergency Use of Certain In Vitro Diagnostic Devices for 2009 H1N1 Flu

The Food and Drug Administration (FDA) is announcing the issuance of 10 Emergency Use Authorizations (EUAs) for certain in vitro diagnostic devices, including an amendment to the CDC Swine Influenza Virus Real-time RT-PCR Detection Panel, in response to a public health emergency involving the 2009 H1N1 flu. The EUAs were issued under the Federal Food, Drug, and Cosmetic Act, following a determination by the Acting Secretary of the U.S. Department of Health and Human Services that a public health emergency exists involving national security.