[Video] Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
By EsqSocial Corporation 02/05/25
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment vacates the agency’s controversial final rule of May 6, 2024 (the “Final Rule”), regulating LDTs as medical devices, just weeks before the Final Rule’s initial implementation deadline and remands the issue back to the FDA for further consideration. Key Takeaways 1.)...
By: Epstein Becker & Green