Hacker News Reader

Thanks! So if a doctor uses one of the GPTs like GPT-4 in a similar way to how they use Google today, it also wouldn't be a medical device I guess. But if someone wanted to make a MedGPT for doctors then that one would probably be subject to the FDA regulations because it will have an 'expected use' for doctors.

View on HN

Essentially yes, assuming MedGPT is marketed to clinicians as being a tool they can use for diagnosis/treatment.

The process is pretty involved, but to add some clarification - the "indications for use" or "expected use" are things the manufacturer are required to include with their device when submitting for 510k clearance from FDA, so that it can then be marketed for medical use. They can only market it as a medical device once it has 510k from FDA.

Reply on news.ycombinator.com