Congress Will Not Tinker With FDA LDT Guidance Before Final, Staffers Indicate
This article was originally published in The Gray Sheet
Both Democratic and Republican staffers on key congressional health committees say that members pushing forward a Senate “medical innovation” bill and backing “Cures” legislation in the House will not interfere with FDA’s proposed plan to regulate laboratory developed tests before the guidance is made final.
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Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.
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