American Clinical Laboratory Ass’n v. FDA

The 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA) authorize the Food and Drug Administration (FDA) to regulate medical devices. Although the FDA has long exercised this authority to regulate diagnostic tests, the FDA has historically exercised its enforcement discretion to refrain from regulating so-called laboratory-developed tests – that is, tests manufactured by laboratories for use in the diagnosis and treatment of diseases. In 2024, in light of the increasing use and complexity of those tests in diagnosing disease and developing treatment protocols, the FDA issued a rule concerning application of its authority to laboratory-developed tests. The industry then challenged the FDA’s rule in federal district court in Texas.

On behalf of itself, the American Cancer Society Cancer Action Network, Association For Clinical Oncology, Friends of Cancer Research, National Brain Tumor Society, and Ovarian Cancer Research Alliance, Public Citizen filed an amicus brief supporting the FDA. The brief argued that the FDA’s rule is supported by the statutory text and is justified by the increasing use and complexity of laboratory-developed tests. The brief explained that a federal statute, the Clinical Laboratories Improvement Act, which regulates laboratory procedures and personnel, did not displace the FDA’s authority to regulate laboratory developed tests under the FDCA. Unfortunately, in March 2025, the district court vacated the FDA’s rule, concluding that laboratory-developed tests are not “devices” subject to the FDA’s regulatory authority.