How Predetermined Change Control Plans let AI/ML-enabled device makers pre-authorize specific model updates without a new marketing submission, what FDA expects a PCCP to contain, and how PCCPs are reshaping AI device regulatory strategy.

FDA's Digital Health Center of Excellence has published a discussion paper on regulating generative AI-enabled medical devices, posing 26 detailed questions with a public comment docket open through October 19. What it signals about where FDA's thinking is headed, and how sponsors should respond.