• Device operation must be independent of clinician (i.e. set it and forget it).

• Approval must be full approval.

Context

The FDA has approved several medical devices for surgical assistance, in particular for surgical imaging and assisting surgeons with robotic surgery. However, these robots are not autonomous: they generally are marketed as making surgeon-guided surgeries safer (reducing radiation exposure for the surgeon and error rate for the patient) or enabling telemedicine (enabling a very experienced surgeon to control the surgery from afar). There are several large companies (and many startups) pursuing autonomous surgery. It looks like FDA approval will be gradual, first approving robotic surgery, then approving AI-assisted surgery, etc. To my knowledge, the FDA has not yet approved any devices for autonomous operation.

Edit: In the case the US FDA is renamed, dissolved, or restructured, this question will be edited to replace "FDA" with the most similar exisiting alternative.