A Discussion on the Regulatory Requirements for LDTs

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs). LDTs have historically not been subject to significant regulatory oversight, and while the FDA aims to promptly release the final rule on this intricate issue laden with complexities, potential roadblocks may delay its course of action. Bridgette, Joanne, and Ben discuss this and also cover: • What is a laboratory developed test (LDT) • Where LDTs sit from a regulatory perspective • What industry stakeholders are saying about these rules • What the proposed rules mean • Why the FDA is stepping in now