Issue Date: September 25, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket
Status: Draft
Robotically-Assisted Surgical Devices – Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled “Robotically-Assisted Surgical Devices–Premarket Submissions.” This draft guidance provides draft recommendations for premarket submissions for robotically-assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.
Download the Guidance Document
