FDA's New Predetermined Change Control Plan Rule for Radiological AI Software, Explained

On June 17, 2026, the FDA introduced a new regulation under 21 CFR 892.2055, classifying radiological machine learning-based quantitative imaging software with a predetermined change control plan (PCCP) as a Class II device with special controls. This new category provides a structured pathway for such software, previously defaulted to the more stringent Class III, enabling a streamlined 510(k) route to market. The PCCP allows for pre-agreed modifications to be validated without requiring new submissions for each update, emphasizing the importance of consistent documentation and data governance. The regulation demands rigorous data management, including documented annotation methods, independent test sets, and measurable performance metrics, transforming these requirements into integral parts of the development process. Encord supports compliance by offering tools for data management and annotation, ensuring that the necessary documentation and validation processes are seamlessly integrated into the workflow.

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