Predetermined Change Control Plans: A Quick-Reference Summary
A Predetermined Change Control Plan (PCCP) is a document, submitted as part of a 510(k), De Novo, or PMA, that describes the modifications a manufacturer anticipates making to an AI/ML device after authorization and the methodology used to implement and validate those changes without a new premarket submission for each one. FDA's guidance requires three core components: a description of planned modifications, a methodology for implementing and validating each one, and an impact assessment addressing safety and effectiveness.
A PCCP does not exist in isolation -- it is an extension of your device's software lifecycle documentation and Design Controls under 21 CFR 820.30, and it must be operationalized through your Quality Management System, not treated as a submission-day checkbox.
For the full picture of what a PCCP is, when your device needs one, and how it fits into your broader AI/ML regulatory strategy, see ADB's AI/ML SaMD regulatory strategy guide. If you've encountered FDA's older SaMD Pre-Specifications (SPS) / Algorithm Change Protocol (ACP) terminology and want to see how it maps to the current framework, see PCCP Terminology: From Legacy SPS/ACP to the Modern Framework.
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