Guidance for Industry and FDA Staff: In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency   [open pdf - 144KB]

"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.' […].This document applies to 2009 H1N1 tests while the declaration of emergency under § 564(b) of the FD&C Act concerning 2009 H1N1 Influenza (H1N1) is in effect. See 21 U.S.C. 360bbb-3(b)(2) regarding the termination of a declaration of emergency. FDA is issuing this level 1 guidance for immediate implementation consistent with the agency's good guidance practices regulation (21 CFR 10.115). FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)) because the agency must act immediately to protect the public health during the declared emergency concerning 2009 H1N1 Influenza. The guidance represents FDA's policy for 2009 H1N1 tests that are already being offered for clinical use on the date the guidance is issued, as well as for any new 2009 H1N1 tests. The information contained in this guidance document should facilitate the submission of EUA requests for 2009 H1N1 tests to FDA by those who wish to pursue such requests."

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