The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024. “Laboratory Developed Tests: Small Entity Compliance Guide” outlines a phased integration of LDTs into […]
The post Impact of New FDA Laboratory Developed Tests Policy appeared first on StarFish Medical.