FDA's 2026 AI Device Scrutiny: Lifecycle Governance and Real-World Performance

Medical Device Global Market Access · Mar 24, 2026 · 2m

This episode explores the FDA's expected regulatory landscape for AI-enabled medical devices in 2026. We discuss the critical shift from pre-market assessment to a total product lifecycle approach, focusing on the non-negotiable requirements for real-world performance monitoring and Predetermined Change Control Plans (PCCPs). Learn what will separate scalable, approvable medtech platforms from demo-grade algorithms that cannot withstand long-term regulatory scrutiny. - How will the FDA's definition of 'safe and effective' for AI devices change by 2026? - What is a Predetermined Change Control…