Zdrowie i gospodarka · 21.06.2010
Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability
The Food and Drug Administration (FDA) is announcing the issuance of seven Emergency Use Authorizations (EUAs) (the Authorizations), two of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA is issuing the Authorizations and amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow the determination by the then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (the Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted