Predetermined Change Control Plan Guide

FDA has published a guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, to provide a “forward-thinking approach to promote the development of safe and effective artificial intelligence-enabled medical devices.” The document specifically provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more artificial intelligence device software functions. It recommends that a PCCP describe the planned software function modifications and the associated methodology to develop, validate, and implement those modifications, plus an assessment of their impact.

The guidance contains an Introduction, Background, Scope, Definitions, Policy for Predetermined Change Control Plans, Description of Modifications, Modification Protocol, Impact Assessment, and two Appendices.