FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus
The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sibelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA requests.