FDA Releases Guidance for Emergency Use of In Vitro Diagnostic Tests for 2009 H1N1 Influenza

Summary

The Food and Drug Administration (FDA) has made available a guidance document outlining its recommendations for in vitro diagnostic devices intended to diagnose 2009 H1N1 Influenza virus infections during the emergency declared on April 26, 2009, by the Secretary of the Department of Health and Human Services.