FDA Issues Draft Guidance for Robotically Assisted Surgical Devices

The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining recommendations for manufacturers developing and seeking authorization for robotically assisted surgical devices. The guidance provides manufacturers with information on the evidence and testing that may be required when submitting these devices for regulatory review.

Robotically assisted surgical devices are software-controlled systems designed to help qualified healthcare professionals position and control surgical instruments during open, minimally invasive and endoluminal procedures. These systems operate under the direct control or supervision of a healthcare professional and may include automated functions intended to support surgical procedures.

The draft guidance addresses several aspects of device development and evaluation. Manufacturers are advised to provide detailed information about the system architecture, including the surgeon's console, robotic components, surgical instruments, software and associated safety features.

The FDA has also outlined considerations for evaluating system performance. These include the accuracy of instrument movement, motion control, visualisation, system stability, response time and other factors that may affect the safe operation of the device. Manufacturers are expected to demonstrate that the system performs consistently under defined operating conditions.

Software and cybersecurity are also addressed in the draft recommendations. Manufacturers are encouraged to identify potential cybersecurity risks associated with connected devices, networks and other digital components. Where robotic systems incorporate automated or artificial-intelligence-based functions, manufacturers may need to provide information concerning those functions and their performance.

The FDA has invited manufacturers, healthcare professionals and other interested parties to submit comments on the draft guidance. The agency plans to consider the feedback received before finalising the recommendations.

The guidance represents the FDA's effort to establish a clearer regulatory framework for the increasing range of robotically assisted surgical technologies being developed for clinical use.

25-09-2026