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.

FDA's voluntary Quality Management Maturity Program is quietly building toward a real quality rating system. Here's what it measures and what's at stake.

Accelerated approval gets discussed constantly in the abstract — surrogate endpoints, confirmatory trials, the theoretical risk of a drug reaching market on thinner evidence. A decision earlier this month gives a live, current example of what that pathway actually looks like in practice, end to end. On July 7, 2026, FDA granted accelerated approval to Vera Therapeutics' atacicept-vymj, to be marketed as Trutakna, for reducing proteinuria in adults with primary IgA nephropathy

FDA just closed one of the more debated gray areas in device submissions — and industry has one week to get ready for the follow-up discussion. On May 29, FDA finalized its guidance on Human Factors information in device marketing submissions, replacing the 2022 draft.