Robotic medical devices are moving toward greater autonomy and remote operation faster than the regulatory vocabulary for describing them has settled. This hybrid two-day workshop — –, 10 a.m. to 4 p.m. ET each day — is CDRH's forum for working through benefit-risk, human factors and cybersecurity questions with the people who build, review and use these devices.

Dates, venue and registration

  • Workshop: 2–3 December 2026, 10 a.m.–4 p.m. ET each day
  • Venue: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Room 1503 — Great Room, Silver Spring, MD 20993
  • Webcast: link emailed to registered virtual attendees before the workshop; archived recording posted afterward
  • In-person registration: free, first-come first-served, closes 23 November 2026 or at capacity
  • Virtual registration: free, remains open after the in-person deadline
  • Organizer: FDA Center for Devices and Radiological Health (CDRH)

What it covers

The workshop gives CDRH a forum to engage device manufacturers, regulatory affairs professionals, healthcare providers, patients and the public on real-world experience with robotic medical devices designed to interact with patients under autonomous or remote-teleoperated control. Sessions are built around the technical, safety and regulatory challenges of increasing device autonomy: human-factors testing, emergency and failure procedures, software interoperability, and cybersecurity requirements, alongside a working discussion of the terminology CDRH uses to describe levels of autonomy and remote control.

Who should attend

Regulatory affairs and quality leaders at companies developing autonomous, semi-autonomous or teleoperated robotic devices, plus human factors, software and cybersecurity specialists who will need to speak CDRH's emerging vocabulary for device autonomy. Tracking device cybersecurity more broadly? RAPS's workshop on unauthorized device cybersecurity covers adjacent ground, and the full events directory lists everything we have verified.

Frequently asked questions

When and where is the FDA robotic medical devices workshop?

2–3 December 2026, 10:00 a.m.–4:00 p.m. ET each day, hybrid: in person at FDA White Oak Campus, Building 31, Room 1503 — Great Room, 10903 New Hampshire Avenue, Silver Spring, MD, and by webcast.

Is the workshop free to attend?

Yes, per the FDA event page. Registration is free and first-come, first-served; in-person registration closes 23 November 2026 or once the room fills, whichever comes first. Virtual registration stays open after that date.

Can I attend virtually?

Yes. The workshop is hybrid; registered virtual attendees receive a webcast link by email before the event, and an archived recording is posted afterward.

What does the workshop cover?

CDRH's engagement with manufacturers, regulatory affairs professionals, healthcare providers and patients on autonomous and remote teleoperated robotic medical devices — human-factors testing, emergency procedures, software interoperability, cybersecurity requirements, and the terminology and benefit-risk considerations tied to increasing device autonomy.

Sources & further reading

  1. FDA. Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities — 12/02/2026. fda.gov
  2. MassDevice. FDA to hold robotics regulation workshop. massdevice.com

Event details are published by the organizer and can change. Confirm dates, format and registration with the FDA before making plans. Verified via WebSearch corroboration (direct organizer-page fetch was blocked this session) — last checked 25 September 2026.