FDORA — Predetermined Change Control Plans for AI/ML Medical Devices
United States (Federal) | H.R. 2617 (Pub. L. 117-328), Div. FF, Title III, Section 3308
Categories
Key Requirements
Adds Section 515C to the FD&C Act authorizing FDA to approve predetermined change control plans (PCCPs) for medical devices. Manufacturers with an approved PCCP can update AI-enabled device software without submitting a new application for each modification, as long as changes are consistent with the pre-approved plan.
Regulated Parties
AI/ML medical device manufacturers seeking 510(k) clearance, De Novo authorization, or PMA approval
Enforcement
FDA (Center for Devices and Radiological Health)
Sources
Notes
Critical statutory authority for adaptive AI/ML medical devices. FDA issued final PCCP guidance on December 3, 2024, specifically for AI-enabled device software functions.
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