Public | Other

Event Title

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

December 2 - 3, 2026

Date:: December 2 - 3, 2026

The U.S. Food and Drug Administration (FDA) is hosting a hybrid two-day public workshop to advance the understanding of autonomous and remote teleoperated robotic medical devices. The workshop will provide a forum for FDA’s Center for Devices and Radiological Health (CDRH) to engage with the community, including, but not limited to, device manufacturers, regulatory affairs professionals, healthcare providers, patients, and the general public, on their experiences with robotic medical devices designed to interact with patients. The discussion will focus specifically on robotic medical devices with autonomous and/or remote teleoperation capabilities, with the goal of deepening the FDA's understanding of user experience and fostering an exchange of ideas that can support the evaluation of benefits and risks to promote patient safety and device effectiveness.

Overview

Since the first robotic medical device was authorized in the United States in the 1990s, the FDA has spent more than 30 years working to assure patients have access to safe and effective robotic medical devices. Throughout this history, the Agency has engaged with stakeholders including, but not limited to, during the 2015 Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities public workshop. As these devices continue to evolve, particularly those with autonomous and/or remote teleoperation capabilities, the FDA believes proactive and sustained engagement with the broader robotic medical device community is essential.

This public workshop continues FDA’s efforts to be adaptive and science-based, supporting innovation while upholding rigorous standards for safety and effectiveness. Workshop discussions aim to:

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.

Location

Attend In Person or Virtually
Virtual: Via webcast
In Person: FDA’s White Oak Campus, Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue, Silver Spring, Maryland 20993
FDA Campus Information (e.g., local airports, directions, and local hotels)

Registration

Register to attend the Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities using the link below. Registration is free and available on a first-come, first-served basis. Early registration is recommended as in-person seating is limited. Registration for in-person attendance will close on November 23, 2026, or once maximum capacity is reached. Virtual registration will remain open after this date. The webcast link will be emailed to registered virtual attendees prior to the workshop start date. The link for the archived webcast will be posted for viewing after the workshop.

Event Materials

The public workshop agenda and pre-workshop materials are forthcoming and subject to change.

Questions

Email questions to CDRHRoboticsWorkshop@fda.hhs.gov.

Learn more about Robotic Medical Devices.