FDA seeks comments on discussion paper about benefits and risks of autonomous robotic medical devices

The Food and Drug Administration is seeking feedback on a discussion paper released Nov. 6 on the benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities. The paper discusses devices intended for surgical procedures and those with nonsurgical applications such as positioning or controlling instruments or imaging tools to perform specific tasks. Comments on the paper are due by Jan. 5, 2027. The discussion paper follows guidance the agency released in September that includes recommendations on nonclinical testing, clinical data and labeling for premarket submissions of certain robotically-assisted surgical devices. The FDA seeks comments on the draft guidance by Nov. 24.