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# Robotically Assisted Surgical Devices Guidance
- URL: https://www.fdaweb.com/robotically-assisted-surgical-devices-guidance/
- Published: 2026-09-24T11:14:00.000Z
- Updated: 2026-11-05T18:57:49.000Z
- Author: David McFarland
- Tags: Devices

FDA has published a draft guidance, *Robotically-Assisted Surgical Devices—Premarket Submissions*, with recommendations for premarket submissions for certain robotically-assisted surgical devices (RASDs). The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/robotically-assisted-surgical-devices-premarket-submissions?ref=fdaweb.com) applies to RASDs except pre-operative planning systems and stereotaxic systems. It also does not address RASDs intended to assist in performing surgical tasks involving the placement or use of interventional devices, such as interventional catheters. Finally, it does not address remotely teleoperated RASDs or autonomous robots that perform significant aspects of operative procedures independent of qualified practitioners.

FDA says that for RASDs outside the guidance’s scope, it recommends that manufacturers engage with the agency through the Q-Submission program to obtain more detailed feedback on their devices.

The agency [says](https://content.govdelivery.com/accounts/USFDA/bulletins/42c2faf?ref=fdaweb.com) it will hold a public workshop on “Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities” on 12/2-12/3.