FDA Announces Discussion Paper on Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities
FDA Announces Discussion Paper on Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities
The U.S. Food and Drug Administration (FDA) is releasing a discussion paper, Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities: Discussion Paper and Request for Feedback. This discussion paper seeks early stakeholder input and broader dialogue on topics such as terminology, benefits and risks, and risk mitigations related to robotic medical devices with autonomous and/or remote teleoperation capabilities. This paper is intended for discussion purposes only and does not represent draft or final guidance. The FDA is also reminding stakeholders of the upcoming public workshop on Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities, taking place December 2–3, 2026. The workshop is open to all and will cover the topics addressed in this discussion paper.
Submit comments on this discussion paper
The FDA encourages feedback from the robotics community, including but not limited to, device manufacturers, regulatory affairs professionals, healthcare providers, patients, and the general public to be submitted under docket number FDA-2026-N-13135 on Regulations.gov, by January 5, 2027.