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.
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Predetermined Change Control Plans for AI and ML-enabled Medical Devices
This resource builds on FDA and global regulatory frameworks to guide stakeholders in planning and implementing iterative improvements to AI/ML-enabled medical devices. It offers insights on creating a Predetermined Change Control Plan (PCCP), including key elements like Description of Modification (DOM), Modification Protocol, and Impact Assessment, to manage post-market changes while maintaining device safety and effectiveness.
AI/ML Working Group
Active AI/ML Working Group members represent the following IVD stakeholders:
- Agilent
- Becton Dickinson
- Escavo
- Philips
- Precision Medicine & Diagnostics
- Roche