A Predetermined Change Control Plan (PCCP) is the section of a marketing submission where you tell FDA, in advance, what changes you plan to make to an AI-enabled device software function (AI-DSF), how you will develop and validate them, and what their impact will be. Once FDA authorizes it with your device, you can ship those changes without a new submission each time, as long as you follow the plan. Get the plan wrong and every update becomes a deviation, which usually means a new submission.

This toolkit walks regulatory, data science, and quality through building one together, grounded in FDA's August 2025 final guidance and the 2023 FDA, Health Canada, and MHRA guiding principles. It covers an eligibility check, a planning checklist for all three PCCP components, a drafting template that mirrors the Description of Modifications, Modification Protocol, and Impact Assessment structure FDA expects, and a final pre-submission pass. Each section maps to what a reviewer actually looks for.