FDA Oversight of Laboratory Developed Tests (LDTs): Where are we and where are we going?
Tue 10:30 AM - Track 3: Regulations and Standards
Katherine Serrano
Food and Drug Administration
View Long Abstract
Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to laboratory developed tests (LDTs), a class of in vitro diagnostics (IVDs) that are designed, manufactured and offered, within a single laboratory. In July 2010, the FDA held a two-day public workshop to create a forum for interested stakeholders to discuss the Agency’s plans of providing greater regulatory oversight for LDTs. FDA has performed analysis on all comments received in conjunction with the public workshop and will use this information to guide the agency policy moving forward.