PCCP for AI/ML Devices: A Quick-Reference Summary

PCCP for AI/ML Devices: A Quick-Reference Summary

A Predetermined Change Control Plan (PCCP) is a document submitted as part of an AI/ML device's 510(k), De Novo, or PMA that describes the modifications a manufacturer anticipates making to the device after authorization, along with the methodology used to implement and validate those changes without a new premarket submission for each one. FDA's PCCP guidance requires three core components: a description of planned modifications, a modification protocol describing how each change will be tested and validated, and an impact assessment evaluating the effect of those changes on safety and effectiveness.

A PCCP is not optional paperwork -- it is a binding part of your marketing authorization once cleared, and it must be operationalized through your Quality Management System under 21 CFR Part 820, 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. For a section-by-section walkthrough of what actually goes into a PCCP's planned-modifications and impact-assessment sections, see PCCP Structure: What Goes in the SPS and IPS Sections.