On September 25, 2026, the FDA issued draft guidance on premarket submissions for robotically assisted surgical devices (RASDs). It covers a wide range of topics, from device descriptions and performance testing to software, training, human factors, reprocessing, and labeling. Within each topic, the draft guidance covers the significance and current recommendations.
This article focuses on three sections especially relevant to how people use these systems: human factors, training, and reprocessing.
The guidance is currently a draft and open for comment, so FDA may change its recommendations before finalizing the guidance.
Human Factors: Evaluating the System As It Is Used
FDA recommends assessing use-related risk early in development and evaluating the device iteratively. Once the user interface represents the final design, manufacturers should conduct human factors validation testing. The draft highlights three recommendations when designing and developing RASD technology:
- Utilizing human factors processes and testing to understand use-related device hazards
- Implementing risk mitigation strategies to minimize those hazards
- And demonstrating that the device can be used without serious errors for intended uses, by the intended users, and under intended conditions.
This follows FDA’s broader human factors guidance for medical devices. However, the RASD draft does add detail about the tasks and interactions that deserve attention for these systems.
For example, FDA specifically mentions addressing surgical planning, instrument preparation, connections to other systems, port switching, and instrument removal and exchange. It recommends assessing each instrument separately. Manufacturers should also consider different system configurations, features that enhance users’ capabilities (even if optional), and whether device movements or position interfere with the team’s workflow. Manufacturers should also evaluate emergency procedures, including stopping the system or withdrawing from the patient.
The guidance gives particular attention to how the surgical team works together. A surgeon may operate the console while an assistant interacts with another part of the system at the same time. If those interactions happen at the same time during actual use, FDA recommends considering those simultaneous interactions when selecting participants and designing validation studies. Testing teams together may reveal issues with communication, coordination, or access to the device that would be difficult to observe when evaluating each role separately.
FDA also asks manufacturers to consider users’ prior experience. Having no or different experience with RASDs may affect how someone interacts with the system and could lead to use errors. Consider both groups when evaluating the device.
Training: Demonstrating Competency Across User Groups
The training section focuses on whether users can competently operate the RASD before clinical use. FDA recommends that manufacturers develop an effective training plan, demonstrate its effectiveness, and provide an overview of the plan in the premarket submission.
Training should address more than the surgeon. Bedside assistants, scrub nurses, and other operating room staff may each need to perform different tasks with the system. The guidance recommends considering their roles, clinical backgrounds, and experience with other RASDs when developing training. It identifies several possible approaches, including instruction on system features, simulation, and use of the device in bench, animal, or cadaver models.
The guidance also calls for specific criteria to evaluate whether training is effective. The guidance also recommends reevaluating existing training when changes to the user interface are introduced, including new instruments or user groups.
Reprocessing: Preparing Components for Use
While the draft guidance refers to the FDA’s reprocessing guidance, it gives reprocessing its own section because many RASD components are reused. Other components may be single-use items that are non-sterile and require sterile processing before use. The FDA’s draft discusses how these components should be adequately cleaned, disinfected, or sterilized, as appropriate.
Some RASD components present particular challenges. Small lumens and hard-to-reach surfaces can be difficult to clean. Other components in the sterile field may be too large to sterilize, such that users clean and disinfect those components before covering them with a sterile drape. Manufacturers should validate reprocessing methods under conditions that reflect the real world, including appropriate soiling. This applies to manual and automated cleaning.
Research Collective’s Perspective
This FDA draft guidance provides more specific direction on evaluating RASDs, including details that matter for human factors testing. It draws attention to interactions across the surgical team and across different components of the system. It also emphasizes training effectiveness, and suggests manufacturers to show that training helps each user group perform its tasks competently.
For human factors teams, the starting point is to identify everyone who interacts with the RASD and what they do. That includes work at the console, work at the bedside, and tasks before and after a procedure. Manufacturers should consider those interactions during development and represent them realistically when testing the final design.
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