Every medical device company reaches the same fork in the road: which FDA pathway fits the device in front of them. Choosing wrong doesn’t just cost time — it can mean building an entire evidence package for the wrong evidentiary standard, then rebuilding it under regulatory pressure. This article walks through how the three primary pathways — 510(k), De Novo, and PMA — actually differ in practice, and how sponsors should be thinking about the decision in 2026. The Core Disti
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.
