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No because google is not marketing their service for medical use. The doctor is responsible for the diagnosis/prescription, which they’re allowed to use any too
by neandrake 4y ago
No because google is not marketing their service for medical use. The doctor is responsible for the diagnosis/prescription, which they’re allowed to use any tool they deem necessary.
Medical devices are marketed for specific medical use, which doctors rely upon to do what’s medically expected. These devices will have an “expected use” and “indications for use” that largely cover how they are design/expected/tested for use. They need 510k clearance to be classified by the FDA as a medical device.
- ftxbro 4y agoThanks! 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.
- neandrake 4y agoEssentially 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.