FDA classification of ML-based quantitative imaging software (with PCCP)

Current understanding

FDA is classifying radiological machine learning-based quantitative imaging software that includes a Predetermined Change Control Plan (PCCP) as Class II medical devices subject to special controls. For developers, this establishes a defined regulatory pathway that permits pre-authorized model updates under a PCCP without new submissions for each change; for platforms/clinical deployers, devices in this category must meet the enumerated special controls covering performance validation, labeling, and change management; for users (clinicians and patients), the goal is safer and faster access to iteratively improved AI imaging tools. Status: final rule.

Evidence log

• 2025-10-09 — Right to Override Act: cross-connection with right-to-override-act: Both address healthcare AI oversight — FDA’s rule governs the device-side approval of ML clinical tools, while Right to Override governs the labor-side ability of clinicians to override such tools in practice. (novelty: 4)

Open questions

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