Many people in the healthcare profession know that clinical laboratories are under more rigorous regulatory scrutiny than just about any other area of medicine. What they may not know is that the New York State Department of Health (NY DOH) was the pioneer in laboratory regulation, starting long before the implementation of either the FDA Medical Device Amendments or the Clinical Laboratory Improvement Amendments (CLIA) of 1988. In this interview, Beverly Rauch, MS, director of the NY DOH’s Clinical Laboratory Evaluation Program (NY CLEP), describes its process for granting permits, inspecting laboratories, and approving assays, and what the new FDA LDT rule might mean for the program.