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Proposed Rule Would Apply FDA’s Diagnostic Rules To LDTs

 
• By Elizabeth Orr

A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion

FDA entrance sign 2016

US Food and Drug Administration officials have been promising to issue a rule to regulate lab-developed tests since legislative efforts fell apart late last year. And those promises came to fruition early Friday, as the agency issued an 83-page proposed rule.

The rule, which had cleared the Office of Management and Budget only the day before, will be published in the...

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