> software as a medical device
I had a question about this earlier, if a doctor uses Google to look up something, then is Google being used in some legal or regulatory sense as a medical device?
I had a question about this earlier, if a doctor uses Google to look up something, then is Google being used in some legal or regulatory sense as a medical device?
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.
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.