Put It on the Board
September 2024—The Association for Molecular Pathology and pathologist Michael Laposata, MD, PhD, announced on Aug. 19 the filing of a lawsuit challenging the Food and Drug Administration rule that regulates laboratory-developed test 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 and Human Services; and Xavier Becerra, in his official capacity as secretary of HHS.