The FDA is asking for public feedback on how it should weigh the benefits and risks of robotic medical devices that act autonomously or are controlled remotely, according to a discussion paper the agency’s Center for Devices and Radiological Health released Nov. 6. Comments are due Jan. 5, 2027.
The paper, “Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities,” covers robotic devices that perform diagnostic, therapeutic or rehabilitative tasks on human anatomy with some autonomy or through remote teleoperation. It seeks early input from manufacturers, providers, patients and the public on terminology, the benefits and risks of autonomous and teleoperated capabilities and risk mitigations. The FDA stressed that it is not draft or final guidance and does not communicate its proposed or final regulatory expectations.
The agency said autonomy and remote operation could expand access to specialized care and improve procedural accuracy, reproducibility and workflow efficiency while raising risks, including incorrect autonomous execution, reduced user vigilance and limited adaptability when procedures deviate from expected variability. The paper’s scope includes imaging and other nonsurgical uses, such as technicians remotely performing ultrasounds.
Examples of autonomous functions cited by the FDA include the agency’s authorization of Vitestro’s Aletta, the first standalone robot that can draw blood without hands-on operator intervention, for adults in outpatient settings under the supervision of a trained phlebotomist.
The paper follows the FDA’s September draft guidance on robotically assisted surgical devices, with comments due Nov. 24, and precedes a hybrid public workshop on autonomous and remotely teleoperated robotic devices scheduled for Dec. 2-3.
U.S. experiments are underway under investigational device exemptions. On Oct. 25, a surgeon at Altamonte Springs, Fla.-based AdventHealth performed a robotic prostatectomy on a patient 35 miles away, after operating from Florida on a patient in Angola in 2025.
