Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

The FDA’s guidance on Predetermined Change Control Plans (PCCP) offers clear recommendations for integrating AI-enabled device software functions into the medical device industry. This framework allows manufacturers to implement pre-approved modifications to their AI-driven software without requiring new marketing submissions, streamlining the regulatory process. By addressing the unique needs of AI algorithms, such as ongoing updates and improvements, the PCCP ensures that these advancements maintain safety, efficacy, and compliance. The FDA emphasizes transparency and monitoring, enabling medical devices to evolve while adhering to rigorous regulatory standards. This innovative approach fosters AI innovation, empowering companies to deploy responsive and adaptive AI-enabled medical technologies that enhance patient care and outcomes.