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COVID-19: FDA Official Announces 200 EUAs, Clarifies Human Factors Testing Rules

 
• By Elizabeth Orr

The US FDA’s diagnostics chief also addressed school screening and post-pandemic approval plans during a recent webinar.

Coronavirus

The US Food and Drug Administration hit an important milestone this week, as the agency granted its 200th Emergency Use Authorization (EUA) for a test for COVID-19. That’s more than a test a day since the first authorization went to a test developed by the Centers for Disease Control and Prevention (CDC) on 4 February.

“Without developers like yourselves, we could not have achieved that goal,” Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices...

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More from Policy & Regulation

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