November 2024—The College of American Pathologists on Oct. 7 filed an amicus brief in support of the plaintiffs in the consolidated cases American Clinical Laboratory Association, et al., v. U.S. Food and Drug Administration, et al., and Association for Molecular Pathology, et al., v. U.S. Food and Drug Administration, et al. Plaintiffs in these consolidated cases challenge a final rule setting out the FDA’s plan to regulate LDTs as medical devices under the Federal Food, Drug and Cosmetic Act. “The Final Rule imposes draconian new restrictions—and crushing compliance costs—on the development and use of LDTs,” the CAP says in its amicus brief.