Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) – Draft Guidance October 23, 2014

The FDA held a webinar on October 23, 2014 to discuss the Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) – Draft Guidance. The draft guidance describes a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs). It is intended to provide guidance to clinical laboratories that manufacture LDTs about how the FDA intends to enforce authorities that apply to such laboratories as medical device manufacturers under the Federal Food, Drug and Cosmetic Act. Slides to the webinar are available from the link provided.