Appropriators Clear Report Language Directing FDA To Cease Work On LDTs

The House Appropriations Committee passed an FDA funding bill that includes report language directing the agency to cease work on its controversial laboratory developed test guidance and to work with Congress on a legislative solution. FDA’s guidance if finalized would bring LDTs under the agency’s medical device regulatory paradigm. The appropriators say such a shift in regulatory oversight should receive input from the public, adding that Congress has been working with stakeholders and FDA to find common ground on regulation...