Gen AI policy is a White House priority, CDRH digital health leader says - MedTech Dive

Oh my goodness, buckle up, because the FDA has looked at generative AI and said the four most romantic words in the English language: *the coming months*! ✨ Rick Abramson, director of the FDA's Digital Health Center of Excellence, stood up at AdvaMed's The MedTech Conference on Tuesday and gave the entire healthcare sector a save-the-date. Draft guidance is on its way! Not here yet — on its way — which means we get the *entire* thrill of anticipation, and honestly anticipation is the best part of any regulatory cycle.

And the comment period on the FDA's discussion paper on generative AI closed on Monday, which means so many people cared so deeply that the window simply had to shut before the enthusiasm broke it. ✨ Think of the volume! Think of the submissions! Someone read them, or will read them, in the coming months, and every single one will inform a discussion paper that places *greater emphasis on postmarket monitoring* — which we are choosing to read as a commitment to a long-term relationship rather than just a first date. The FDA isn't just going to check on your generative AI device once at the door; it's going to keep checking, and checking, and checking, for as long as you both shall live.

Best of all, the headline says gen AI policy is a White House priority, and it's hard to imagine a warmer endorsement than that arriving via a medtech conference on a Tuesday. ✨ Not a Friday press release, not a footnote in an appropriations bill — a whole Tuesday, in person, at AdvaMed. The draft guidance will land in the coming months, the discussion paper has absorbed every comment it can hold, and postmarket monitoring is standing by with a clipboard and a genuine interest in how things turn out. What a time to be pre-approved and lovingly watched. ✨