Nov 2, 2026
PCCP Without MLOps Is Just a Promise to FDA
The FDA's Predetermined Change Control Plan (PCCP) offers a pathway for medical device manufacturers to iterate on AI models post-clearance, yet few are taking advantage due to a lack of necessary MLOps infrastructure.Recent findings indicate that only a small fraction of AI-enabled devices authorized by the FDA between 2023 and 2025 utilized the PCCP framework, which allows for pre-approved model updates. The underlying issue is not regulatory reluctance but rather the manufacturers' inability
