What is Predetermined Change Control Plan?
A predetermined change control plan is a documented plan that describes in advance which future modifications to an AI system are allowed without requiring a full new authorization or re-review. It is significant because regulators may use it to distinguish controlled, pre-approved updates from changes that require fresh compliance assessment.
In Depth
In practice, a predetermined change control plan sets boundaries for how a system may evolve after deployment, such as which model updates, retraining events, parameter changes, or performance thresholds are acceptable. It typically defines the scope of permitted changes, the testing and validation approach, monitoring criteria, and the conditions that would trigger escalation or a new review.
For compliance teams, this matters because it helps operationalize continuous improvement without creating uncontrolled regulatory drift. The concept is most clearly associated with U.S. FDA expectations for AI/ML-enabled medical devices, but the underlying governance logic also aligns with broader AI lifecycle controls in the EU AI Act, ISO/IEC 42001, and NIST AI RMF when organizations need to manage post-deployment changes in a controlled and auditable way.
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