FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation

MedDevice Startups Staff · 2 days ago · 2 min read · Via FDA workshop notice

CDRH will hold a public workshop on December 2 and 3 on robotic medical devices that operate autonomously or under remote teleoperation. Both days run 10 a.m. to 4 p.m. Eastern. The format is hybrid: FDA's White Oak campus in Silver Spring, Building 31, Room 1503, or a webcast.

FDA wants input on three things: terminology and technical considerations for these devices, how to weigh their benefits and risks, and what policy should look like. Registration is free and first come, first served. In-person seats close on November 23 or when capacity is reached, and virtual registration stays open past that date. Questions go to CDRHRoboticsWorkshop@fda.hhs.gov. The agenda and pre-workshop materials are still to come.

The notice went up the same day as the draft guidance on robotically-assisted surgical devices, which left autonomy out of scope, and the same day FDA opened a Robotic Medical Devices resource page. If you are building a device that acts on its own, or one a surgeon drives from another building, the workshop is where that scope gets argued. Comments made in December tend to show up in the next draft, and there is no other venue on the calendar.

Questions & Answers

When is the FDA workshop on autonomous and remotely teleoperated robotic medical devices?

CDRH holds the workshop on December 2 and 3, 2026, from 10 a.m. to 4 p.m. Eastern each day. It is hybrid: in person at FDA's White Oak campus in Silver Spring, Maryland, Building 31, Room 1503, or by webcast.

How do I register for the FDA robotic medical devices workshop?

Registration is free and first come, first served. In-person registration for the December 2 and 3, 2026 workshop closes November 23 or when the room fills, and virtual registration stays open after that date. Questions go to CDRHRoboticsWorkshop@fda.hhs.gov.

Does the FDA workshop cover the autonomy left out of the robotically-assisted surgical devices draft guidance?

Yes. FDA's December 2026 workshop takes up terminology, technical considerations, benefit-risk and policy for autonomous and remotely teleoperated robotic devices, the ground the September 2026 draft guidance on robotically-assisted surgical devices kept out of scope.

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