Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency." FDA is issuing this guidance to inform industry and agency staff of its recommendations for the type of information and data FDA believes needs to be included in an Emergency Use Authorization Request (EUA) for in vitro diagnostic (IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus infections during the emergency involving Swine Influenza A\1\. The Secretary of the Department of Health and Human Services (HHS) declared the emergency on April 26, 2009, in accordance with the Federal Food, Drug, and Cosmetics Act (the Act). ---------------------------------------------------------------------------