Artificial Intelligence and Machine Learning for In Vitro Diagnostics
Overview
The AI/ML project aims to build on AI/ML best practices designed for imaging and other applications to develop an industry perspective on a predetermined change control plan (PCCP) for other AI/ML-enabled medical devices, including IVDs.
Predetermined Change Control Plans for AI and ML-enabled Medical Devices
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.
AI/ML Working Group
Active AI/ML Working Group members represent the following IVD stakeholders:
- Agilent
- Becton Dickinson
- Escavo
- Philips
- Precision Medicine & Diagnostics
- Roche