Guidance for Industry and FDA Staff: In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency

摘要

This document provides guidance on the type of information and data that FDA recommends you include in an Emergency Use Authorization (EUA) request for in vitro diagnostic (IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus infections during the emergency involving Swine Influenza A declared by the Secretary of the Department of Health and Human Services (HHS) on April 26, 2009 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Such devices will be referred to in this guidance as '2009 H1N1 tests.'