ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices

ACLA and its member company HealthTrackRx filed a lawsuit against the U.S. Food and Drug Administration challenging the Agency’s Final Rule regulating professional laboratory developed testing services as medical devices under the Federal Food, Drug, and Cosmetic Act.

ACLA is bringing this lawsuit because FDA’s Final Rule exceeds its lawful authority. Laboratory developed testing services are professional services, not manufactured medical devices.

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