FDA Sees ‘Appropriate’ Transition Period for COVID-19 Test EUAs When Public Health Emergency Ends

FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to terminate their authorizations, in anticipation of U.S. public health emergency declarations no longer being in effect. That draft guidance “proposes that there will be at least a 180-day transition period,” Lowe said during Wednesday’s town hall. “The FDA will finalize that guidance once we review the public comments on the draft.”

“The EUA declaration under section 564 does not expire and it is not dependent on the extension of the public health emergency declaration,” Lowe told test makers. “The EUA declaration under section 564 continues until the HHS Secretary terminates it. Many of the previous EUA declarations, such as for MERS, Zika, and Ebola, remain in effect, especially for in vitro diagnostic tests.”

Source: https://www.medtechdive.com/news/fda-transition-period-covid-19-test-euas-when-PHE-ends/621733/