Summary of Court Decision Nullifying FDA Regulations for LDTs

On Tuesday, April 1, 2025, NILA published a story about a Texas District Court's decision to vacate, in it's entirety, the FDA’s rule regulating Laboratory Tests (LDTs), holding that the FDA’s attempt to regulate laboratory services as medical devices exceeds the agency’s statutory authority under the Food, Drug, and Cosmetic Act (FDCA).

NILA attorney Michael Hawrylchak, Esq., has written a summary of the Texas Court's decision, which can be viewed below.

Click here to read Michael Hawrylchak's Summary of decision in ACLA/AMP v. FDA.