Tag: LDT regulation

Association for Molecular Pathology Files Lawsuit Against FDA to Challenge Final Rule on Regulation for Laboratory Developed Testing Procedures

sarah JonasPolicy

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.