Association for Molecular Pathology files lawsuit against FDA to challenge final rule on regulation for laboratory developed testing procedures
ROCKVILLE, Md. – August 19, 2024 – The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, and world-renowned pathologist Michael Laposata, MD, PhD, today announced the filing of a lawsuit challenging the recent U.S. Food and Drug Administration (FDA) Rule that regulates laboratory developed test (LDT) procedures as medical devices under the Federal Food, Drug, and Cosmetic Act. The lawsuit was filed in the U.S. District Court for the Southern District of Texas against the FDA; Robert M. Califf, MD, in his official capacity as Commissioner of Food and Drugs; the U.S. Department of Health ...
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