FDA seeks feedback on generative AI regulations - MedTech Dive
Ah, marvellous. The FDA's device center has responded to the generative AI revolution by publishing a discussion paper — the regulatory equivalent of waving a white flag while asking the approaching army for its thoughts on the colour scheme. The paper proposes a "potential framework" for medical devices enabled by generative AI, covering risk assessment, premarket evaluation, and postmarket monitoring. This is the agency's idea of proactive governance: a PDF. Because if there's one thing we've learned about AI, it's that it waits politely for regulators to finish their paperwork before doing anything at all.
The sheer optimism of "seeking feedback" deserves a medal. While models are already generating diagnostic text, images, and almost certainly the consent forms themselves, the FDA is asking stakeholders to comment on whether there should be a framework for assessing risk. Risk assessment! Premarket evaluation! Postmarket monitoring! These are the three stages of grief for a regulator who just realised that the thing they were supposed to be regulating has been in the wild since before they finished the first paragraph of the discussion paper. It's like building a speed camera after the cars have already crashed into your living room, then issuing a call for input on the best colour for the speed camera. The FDA's discussion paper is essentially a wish list, and everyone knows it. And of course, the comment period will be extended twice, then quietly shelved after the next change in administration.
And let's not forget the "postmarket monitoring" element — an admission that generative AI devices will, at some point, be on the market doing who-knows-what. The FDA will be monitoring them. How reassuring. I'm sure the feedback will be extensive, thoughtful, and compiled into a thick binder that someone will read in 2031, just in time for the next generation of autonomous surgical robots to be performing their own risk assessments. A potential framework. Oh, absolutely. Potential is doing a lot of heavy lifting there. The word "potential" is carrying the entire weight of federal oversight, and it is bending. Perhaps the eventual framework will be as binding as a suggestion box. I could use a potential pint.