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Override: HHS Revokes FDA’s LDT Policies

 
• By Elizabeth Orr

The US department that oversees the FDA says the agency acted beyond its authority in asking labs to file emergency use authorizations, asserting that only CLIA rules should apply.

Pipette adding fluid to one of several test tubes

Creators of laboratory developed tests (LDTs) for COVID-19 don’t need to notify the US Food and Drug Administration before taking the diagnostics to market, the Department of Health and Human Services (HHS) said in a 19 August announcement.

The statement says the FDA won’t impose premarket review on LDTs absent the formal notice-and-comment rulemaking process. The requirement can’t be set via guidance documents, website statements, compliance manuals and...

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More from Policy & Regulation

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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

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