A federal district court March 31 held that the FDA’s final rule regulating laboratory developed tests (LDTs) as medical devices exceeds the agency’s statutory authority and is unlawful (American Clinical Laboratory Association v. U.S. Food and Drug Administration, Nos. 4:24-cv-479-SDJ, 4:24-cv-824-SDJ, 2025 U.S. Dist. LEXIS 59869 (E.D. Texas March 31, 2025)). The U.S. Distri... Read More