Pearl Pathways Blog Implications of FDA’s New Rule on Laboratory-Developed Tests (LDTs) for Clinical Laboratories

On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of diagnostic testing: the new rule governing Laboratory-Developed Tests (LDTs).  Unlike commercially available tests that are subject to premarket approval by the FDA, LDTs were originally intended to be restricted to diagnostic tests that are designed, manufactured, and used within a single […] The post Implications of FDA’s New Rule on Laboratory-Developed Tests (LDTs) for Clinical Laboratories first appeared on Pearl Pathways. The post Implications of FDA’s New Rule on Laboratory-Developed Tests (LDTs) for Clinical Laboratories appeared first on Pearl Pathways.