What is AI-Enabled Medical Device Predetermined Change Control Plan?
An AI-Enabled Medical Device Predetermined Change Control Plan is a pre-approved plan that specifies which future changes to an AI-enabled medical device are permitted without requiring a full new premarket submission. It is significant because it gives manufacturers a structured regulatory path for updating machine-learning devices while maintaining safety and effectiveness oversight.
In Depth
In practice, the plan defines the types of modifications allowed, the methods used to implement them, the performance evaluation strategy, and the acceptance criteria that must be met before a change is released. This allows certain adaptive systems to evolve after deployment while keeping regulators informed about how the device will be controlled, tested, and monitored.
For compliance teams, the plan is central to lifecycle governance, change management, and evidence generation for software as a medical device and other AI-enabled medical products. It is most directly associated with U.S. FDA expectations for AI/ML-enabled devices, and it also supports documentation and post-market monitoring practices that map well to ISO and medical-device quality systems.
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