United States - FDA Regulation of AI/ML-Enabled Medical Devices and Predetermined Change Control Plans

Under the Federal Food, Drug, and Cosmetic Act, the FDA's Center for Devices and Radiological Health regulates artificial-intelligence and machine-learning software that meets the definition of a medical device. Such software must obtain marketing authorization through the 510(k), De Novo or premarket approval pathways, and more than a thousand AI/ML-enabled devices have been authorized. The framework addresses safety and effectiveness, transparency and labelling, and postmarket surveillance of real-world performance.

A central feature for adaptive AI is the Predetermined Change Control Plan. Statutory PCCP authority was added by the 2022 FDORA amendments, and the FDA issued final guidance on 4 December 2024 recommending how manufacturers describe planned future modifications and the methods and testing used to implement them. An authorized PCCP allows specified model changes to be made without a new marketing submission each time. The FDA has also issued draft lifecycle-management guidance for AI-enabled device software functions. Enforcement uses FD&C Act tools including warning letters, seizure, injunction and civil penalties.