S4Ep2: The FDA’s Proposed Rule on Laboratory Developed Tests
Tests that are designed in-house to fulfill a clinical need (but aren’t FDA approved) qualify as laboratory developed tests. And these LDTs are currently regulated by CLIA. But the FDA is proposing a new rule that would give them oversight of the design and development of laboratory developed tests. So, what does that mean for us? How would this new legislation impact everyday practice inside the lab? On this episode of the podcast, your hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Br...