FDA Removes Language On Declining To Review LDT EUAs From Website

By Kelly Lienhard / November 19, 2020 at 2:16 PM
FDA quietly updated its online testing FAQs to reflect HHS’ directive Monday (Nov. 16) that the agency review emergency use authorization applications voluntarily submitted for COVID-19 laboratory-developed tests. FDA told labs in October it would no longer conduct the reviews following HHS’ controversial August pronouncement that FDA lacked jurisdiction over LDTs . FDA’s website still stated the agency was declining to review EUA applications late Monday evening, after the agency’s daily COVID-19 round-up email was already circulated for the day...

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