FDA Predetermined Change Control Plans for AI Devices

A PCCP is a planned change-management component of a medical-device marketing submission. FDA’s August 2025 final guidance gives recommendations for PCCPs tailored to AI-enabled device software functions, including the device constituent part of device-led combination products reviewed through 510(k), De Novo, and PMA pathways. FDA reviews the proposed plan with the marketing submission to assess whether the described changes can be made while maintaining a reasonable assurance of safety and effectiveness. A PCCP does not permit unrestricted changes. The guidance organizes the plan around three elements: a description of planned modifications, a modification protocol for developing, validating, and implementing those changes, and an impact assessment addressing benefits and risks. The planned changes need defined boundaries. The protocol should state methods, acceptance criteria, data controls, validation, implementation safeguards, and monitoring appropriate to the device and proposed change. The impact assessment should explain how changes could affect safety and effectiveness, including interactions among modifications. Vague promises to “retrain as needed” do not provide a meaningful boundary or evidence plan. After FDA authorizes a PCCP, a manufacturer may implement modifications that conform to the authorized plan without a new marketing submission for each described modification. It must still follow applicable quality-system, labeling, reporting, and other regulatory obligations. A proposed change outside the PCCP, or one that fails its protocol, requires a separate regulatory assessment. Depending on the change and device pathway, a new 510(k), De Novo, PMA supplement, or other action may be required. PCCP authorization therefore changes the route for a bounded category of updates; it does not exempt a product from device regulation. The 2025 guidance is final agency guidance and expresses FDA’s current recommendations; guidance does not itself establish legally enforceable responsibilities unless specific statutory or regulatory requirements apply. Manufacturers should distinguish this AI-focused guidance from earlier draft documents and from joint international PCCP guiding principles. Align scope, evidence, risk controls, and monitoring with the device and patient context.