FDA Solicits Feedback on Autonomous Robotic Medical Device Regulation

The U.S. Food and Drug Administration (FDA) is seeking public comments on a discussion paper regarding the benefits and risks of autonomous and remotely operated robotic medical devices. These devices are used in both surgical and non-surgical settings, including for instrument positioning and imaging. The agency's request for feedback, due by January 5, 2027, is part of its ongoing effort to develop regulatory guidance for these advanced technologies.