FDA Charts New Course for AI Medical Devices

The FDA has rolled out draft guidance to steer developers of AI-enabled medical devices toward safety and effectiveness across the entire lifecycle. Key highlights include the Total Product Lifecycle approach, strategies to tackle transparency and bias, and a streamlined process for iterative updates via Predetermined Change Control Plans. Developers have until April 7, 2025, to submit public comments and can join the upcoming webinar for deeper insights. It’s a balancing act between innovation and regulation, with the FDA playing the friendly neighborhood guide.