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When did the FDA grant the test emergency use authorization?

April 26, 2017Authorization emergency fda Test

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When did the FDA grant the test emergency use authorization?

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On July 24, 2009, the FDA announced that it has granted emergency use authorization (EUA) to Focus Diagnostics for its real-time PCR test intended for the in vitro qualitative detection of 2009 H1N1 influenza virus RNA. Focus Diagnostics is the infectious disease business of Quest Diagnostics.The FDA has not cleared or approved this test. Under the EUA, the FDA has only authorized its use for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1). The declaration of emergency will expire on April 26, 2010, unless it is terminated, revoked sooner or renewed. The test is intended to be used on nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), and nasal aspirates (NA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.