We prepare a Predetermined Change Control Plan (PCCP) that defines a structured, prospective framework for managing anticipated changes to a regulated product, process, or system following regulatory authorization. The purpose of this PCCP is to ensure predefined changes are implemented in a controlled, transparent, and compliant manner without compromising product quality, safety, or effectiveness, while maintaining regulatory compliance and oversight.
The PCCP establishes boundaries, controls, and governance mechanisms to execute, verify, document, and approve changes. Changes executed under this PCCP are limited to those explicitly defined herein and are subject to risk-based assessment and predefined acceptance criteria.
Purpose: Enable post-approval AI updates without re-submission failure.
Deliverables
- SaMD change taxonomy (locked vs adaptive)
- Algorithm Change Protocol (ACP)
- Model update validation plan
- Drift monitoring & acceptance thresholds
- FDA-acceptable PCCP narrative
Duration: 4–8 weeks