Predetermined Change Control Plans for AI and ML-enabled Medical Devices

The Artificial Intelligence and Machine Learning (AI/ML) for In Vitro Diagnostics (IVDs) Working Group was established in 2020 to address the challenges surrounding iterative updates to AI/ML-enabled medical devices. This initiative was driven by the need for clear guidelines on maintaining the safety and effectiveness of these evolving technologies.

Building on frameworks released by the FDA and other global regulatory agencies, this resource is intended to help stakeholders understand a possible approach to planning and implementing iterative improvements to AI/ML-enabled medical devices. The resource provides consideration for developing a Predetermined Change Control Plan (PCCP), including essential elements such as the Description of Modification (DOM), Modification Protocol, and Impact Assessment.

Discover how a detailed PCCP is essential for managing post-market changes to AI/ML-enabled medical devices, ensuring future updates are proactively communicated, validated, and maintain the safety and effectiveness of the device.