Congress Will Not Tinker With FDA LDT Guidance Before Final, Staffers Indicate

10 Sep 2015

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.

Capitol Hill staffers are signaling that Congress will not interfere with FDA’s plan to further regulate clinical laboratories via its proposed lab-developed test guidance in the short-term, despite some heavy opposition lobbying from the laboratory industry and various alternative regulatory schemes for diagnostics being floated to lawmakers.

Even before FDA proposed its LDT framework