The U.S. Food and Drug Administration has released draft guidance outlining what manufacturers of robotically assisted surgical devices (RASDs) should include in premarket submissions. The recommendations cover software-controlled robotic systems that help clinicians position and operate surgical instruments during open, minimally invasive and endoluminal procedures. The guidance applies to systems operating under the direct control or supervision of qualified clinicians, including devices with some automated capabilities, but does not address robots that independently perform significant portions of surgery.
The FDA is asking manufacturers to provide detailed descriptions of the complete robotic system, including surgeon consoles, robotic arms, surgical instruments, software, compatible devices and built-in safety mechanisms. Companies should demonstrate that their systems remain accurate and reliable throughout their expected service life and respond appropriately to commands from surgeons.
Performance testing should examine factors including motion accuracy, visual feedback, motion scaling, tremor reduction and system latency. The FDA specifically recommends measuring delays between a surgeon's movement at the console, the corresponding movement of the surgical instrument and the visual feedback displayed to the clinician. Manufacturers should also evaluate potential system failures and demonstrate how devices respond when components or communications do not operate as expected.
Cybersecurity is another major focus of the draft guidance. The FDA recommends evaluating the entire connected environment surrounding surgical robots, including accessories, hospital networks, external servers and cloud services. Testing could include scenarios in which the robot communicates with a compromised hospital network to determine whether cybersecurity incidents could affect device safety or surgical performance.
For robotic systems incorporating artificial intelligence, manufacturers should evaluate the specific AI functionality and identify potential consequences if the technology produces incorrect outputs or behaves unexpectedly. The agency recommends discussing proposed testing strategies with the FDA before submitting AI-enabled robotic devices for review. Manufacturers should also provide appropriate training for surgeons and other healthcare professionals operating the systems.
The guidance remains in draft form and is open for public comment for 60 days. It follows broader FDA efforts to modernize oversight of increasingly sophisticated medical technologies, including recent work exploring regulatory approaches for generative AI-enabled medical devices.
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