Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.

Does an EUA mean the test is now FDA approved?

April 26, 2017Approved eua fda mean Test

0

Posted

Does an EUA mean the test is now FDA approved?

1 Answer

0

Posted

No. The FDA has not cleared or approved the Influenza A H1N1 (2009) Real Time RT-PCR test. The test has been authorized by FDA under an Emergency Use Authorization, and is only authorized 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 or revoked sooner or renewed.