Robotic Medical Devices
Save the Date: December 2–3, 2026
FDA Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities
Join the FDA’s Center for Devices and Radiological Health in person or virtually for a two-day workshop to foster dialogue on robotic medical devices designed to interact with patients, with a focus on devices with autonomous and/or remote teleoperation capabilities.
A robotic medical device is any machine or electrical system that uses robotic technology to improve, assist, or perform tasks in health care, such as surgery, diagnosis, or rehabilitation. Robotic medical devices can be used across a wide range of clinical settings, from minimally invasive surgery to physical rehabilitation. The development of devices that are capable of operating at a distance (remote teleoperation) or performing certain tasks autonomously have the potential to further transform patient care.
This page brings together the FDA’s current efforts and engagement opportunities around regulation of robotic medical devices.
Key Takeaways
- Robotic medical devices such as robotic blood draw, endovascular robots and robotically-assisted surgical devices are regulated by the FDA to ensure safety and effectiveness.
- The FDA is actively engaging with stakeholders to discuss the unique considerations posed by robotic medical devices with autonomous and/or remote teleoperation capabilities.
- The FDA encourages early engagement from device developers working on novel robotic medical devices.
