Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities

The U.S. Food and Drug Administration (FDA) will host a hybrid, two-day public workshop focused on autonomous and remote teleoperated robotic medical devices. The event will bring together a broad range of stakeholders, including device manufacturers, regulatory professionals, healthcare providers, patients, and members of the public, to discuss experiences with robotic technologies designed to interact with patients. The workshop aims to support dialogue on the benefits, risks, and real-world considerations associated with these evolving medical devices.

Workshop Objectives:

• Foster dialogue among stakeholders on terminology and key technical considerations for robotic medical devices with autonomous and/or remote teleoperation capabilities.
• Better understand the probable benefits and risks of robotic medical devices with autonomous and/or remote teleoperation capabilities.
• Explore considerations for future policy development responsive to innovation while maintaining reasonable assurance of safety and effectiveness.

The workshop builds on the FDA’s longstanding engagement with the robotic medical device community and reflects ongoing efforts to better understand emerging technologies. The event will explore challenges and opportunities associated with advancing robotic medical devices while informing future regulatory and public health considerations.

Visit the event page for more information.