Historically, LDTs have been regulated jointly by the FDA and CMS. By the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, Congress gave to FDA the authority to regulate medical devices, while CMS has responsibility for laboratory practice under CLIA. AMP’s complaint calls upon Congress’s purported intent not to have the 1976 Medical Device Amendments cover LDTs for one thing Congress viewed them as distinct from commercially distributed medical devices. FDA Regulatory Oversight: A Course of Action
Despite legal challenges, the FDA is moving forward with implementing the new rule, and compliance is set to start in May 2025. The agency has been criticized by congressmen and trade groups for significantly expanding its regulatory scope, particularly given the recent Supreme Court rulings affecting regulatory deference.
No comment yet from the FDA on the lawsuit. Legal Representation and Case Information
AMP and Laposata are represented by Fred D. Raschke of Mills Shirley LLP and a team from Hyman Phelps & McNamara PC. The case is Laposata et al. v. United States Food and Drug Administration et al., case number 3:24-cv-00241, in the Southern District of Texas, Galveston Division.
