Federal agencies · FDA-2026-N-9505 · Draft guidance

FDA issues draft guidance for robotic surgical devices

Open for commentRecorded action: September 25, 2026

A da Vinci Xi surgical robot at Centre hospitalier de Vesoul in 2023. Related clinical technology. — Related surgical technology: a da Vinci Xi system at Centre hospitalier de Vesoul in 2023. The photograph does not indicate an FDA decision about this device. Image: A.BourgeoisP / Wikimedia Commons · CC BY-SA 4.0 · 4096 × 3182 · Downsampled where needed to 4K or larger and WebP optimized; smaller card preview. No upscaling.

What happened

FDA announced draft guidance for premarket submissions involving robotically assisted surgical devices. Comments are requested by November 24, 2026.

What the draft covers

The draft recommends information for nonclinical and clinical testing and premarket submissions for teleoperated, software-controlled surgical systems that help practitioners position and control instruments.

This is draft, nonbinding guidance and is not final or currently for implementation. FDA says it will consider public comments before developing a final version.

Verified October 27, 2026. This is a RobotMe summary of the official record; it is not legal advice.