Decoding Digital Health: AI/ML Webinar Recap—U.S. FDA & European Perspectives

In this episode of Decoding Digital Health, Kellie Combs, along with partners Greg Levine and Lincoln Tsang, discuss the regulatory landscape surrounding AI and machine learning in medical devices, highlighting key points from their recent webinar. The discussion covers the definitions of AI and ML, the difference between locked and adaptive algorithms, and common use cases, particularly in radiology. They delve into the risk-based approach adopted by regulators, focusing on lifecycle regulation, algorithmic bias, and transparency. The conversation also addresses the regulatory classification of software functions in the U.S. and Europe, upcoming FDA guidance on predetermined change control plans and lifecycle management of AI, international harmonization efforts, and guiding principles for good machine learning practice.