Artificial Intelligence/Machine Learning-enabled

Artificial Intelligence/Machine Learning-enabled (AI/ML) medical devices bring unique opportunities and regulatory considerations when advancing public health. The AI/ML Working Group (WG) seeks to prioritize consensus in the AI/ML sector, where rapid technological advancements and an influx of manufacturers from sectors beyond medical devices is seen. Regulatory consensus for AI/ML has a close interplay with Software as a Medical Device (SaMD) for many jurisdictions, it’s therefore also a priority to maintain alignment with broader software guidance.

The goal of the AI/ML WG is to develop new documentation on the topic of Good Machine Learning Practice (GMLP), to provide internationally harmonized principles to help promote the development of safe and effective artificial intelligence/machine learning -enabled (AI/ML) medical devices.