Federal Court Vacates FDA Rule on Laboratory Developed Testing Services, Siding with ACLA

ACLA and its member company, HealthTrackRx, won a legal challenge against the U.S. Food and Drug Administration’s (FDA) Final Rule that would have regulated virtually all laboratory developed testing services as medical devices. The U.S. District Court for the Eastern District of Texas has vacated the Final Rule in its entirety, holding that FDA’s attempt to regulate professional laboratory testing services as medical devices exceeds the authority granted to FDA in the Food, Drug, and Cosmetic Act (FDCA).