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# FDA Seeks Input on Autonomous and Remote-Controlled Medical Robots
- URL: https://www.fdaweb.com/fda-seeks-input-on-autonomous-and-remote-controlled-medical-robots/
- Published: 2026-11-09T17:54:01.000Z
- Updated: 2026-11-09T17:54:01.000Z
- Author: David McFarland
- Tags: Devices

FDA is seeking public input on how to evaluate the benefits and risks of medical robots capable of performing tasks autonomously or being operated remotely, as advances in artificial intelligence and connectivity expand their potential clinical applications.

In a just-posted [discussion paper](https://www.fda.gov/media/196129/download?ref=fdaweb.com), CDRH identifies regulatory questions involving autonomous decision-making, remote operation, device performance and risk mitigation. The agency will examine the issues during a 12/2–3 public workshop ([see earlier story](https://www.fdaweb.com/fda-workshop-on-autonomous-robotic-medical-devices/)).

The paper addresses robotic systems used in surgery, imaging, navigation, diagnostics and other medical procedures. FDA notes that emerging applications include remotely operated ultrasound systems, robotic blood-drawing devices and systems designed to autonomously locate and stop internal bleeding.

FDA distinguishes between different degrees of autonomy, ranging from systems that assist clinicians to those capable of performing tasks without user intervention. Remote teleoperation presents additional considerations because the operator may not be physically present with the patient.

The agency is seeking feedback on how to characterize these capabilities and assess potential benefits and risks, including the roles of human oversight, device validation, operator training and other safeguards.

The discussion could inform future regulatory approaches as manufacturers develop increasingly sophisticated robotic systems.