FDA AI/ML Medical Device Guidance and PCCP Framework (2021-2024)
The FDA issued guidance between 2021 and 2024 on AI and machine learning in medical devices, establishing a Predetermined Change Control Plan (PCCP) framework allowing manufacturers to describe planned AI model updates in advance. The 2024 guidance provides the most complete framework for how AI-powered medical devices should be developed, validated, and updated.
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Related Legislation
Other policies covering the same harm domain