I have a doubt about the 510K exemption process.
If a device is 510k-exempted, do you still need to submit technical dossier (e.g. information on safety of the device and compliance to 10993, 60601 etc) to FDA?
Or the only things to do should be to perform registration and listing and start to sell the device?
If a device is 510k-exempted, do you still need to submit technical dossier (e.g. information on safety of the device and compliance to 10993, 60601 etc) to FDA?
Or the only things to do should be to perform registration and listing and start to sell the device?