Predetermined Change Control Plan (PCCP)
A regulatory mechanism, formalized in FDA guidance finalized in 2024 for AI-enabled device software, by which a manufacturer specifies in advance the modifications a device may undergo and the methods that will validate them. Changes that fall within the authorized plan can be implemented without a new marketing submission, while changes outside it still require fresh review.
For adaptive BCI decoders this is the leading answer to the 'locked-model' problem. Rather than re-authorizing every retraining or recalibration, the sponsor pre-authorizes a bounded envelope of change — which parameters may adapt, on what data, within what performance guardrails, and under what monitoring.
A PCCP shifts scrutiny from the individual update to the quality of the change protocol itself. Its effectiveness depends on how tightly the envelope is drawn and how rigorously the guardrails and monitoring are enforced: a well-specified plan enables safe iteration; a vague one becomes a blank check.