Diagnosing the Disease: Regulation of LDTs and IVDs

Ben Wolf will present during this virtual program hosted by the Practicing Law Institute (PLI). This program will provide the background and evolution of the FDA’s regulation of laboratory developed tests (LDTs) and in vitro diagnostics (IVDs). It will also cover the FDA’s efforts to regulate LDTs, including a white paper published in early 2017 and a rule issued in May 2024. The session will close with a discussion of the impact of the change in presidential administration and in the consolidated cases American Clinical Laboratory Association v. FDA and Association for Molecular Pathology v. FDA.