Shuren: FDA Open To Better LDT Oversight, Possibly Through Legislation

FDA medical device chief Jeffrey Shuren told Inside Health Policy Tuesday (April 21) that while the agency “certainly has the statutory authority” to put together a regulatory framework for laboratory developed tests (LDTs) that strikes a balance between patient safety and innovation, FDA remains open to ideas and “better solutions that could be effectuated through legislation.” This comes as a coalition of diagnostic manufacturers and clinical laboratories floats an alternative approach for LDT oversight that lays out distinct roles...