FDA draft guidance addresses considerations for robotically assisted surgical devices
The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market. It includes non-clinical and clinical testing requirements that sponsors should include in their premarket submissions.
The draft guidance, published last week, describes RASDs as "teleoperated, software-controlled systems that integrate robotic technologies and subassemblies that are designed to assist qualified practitioners in precisely positioning and controlling one or more surgical instruments to safely and effectively perform open, minimally invasive, or endoluminal procedures." The agency said such devices include robotic technologies that use a leader or follower control system architecture and may have some level of autonomy to enhance their capabilities.
FDA said RASDs generally include an operator console where a qualified user operates the device, and a bedside or patient subassembly that includes tools and accessories that are also controlled by the qualified operator during surgical procedures. Such devices are also typically part of operating rooms or staff subassemblies that include supporting hardware and software for their operation.
FDA also said that pre-operative planning systems and stereotaxic systems are not RASDs and are not covered by the guidance. It also does not cover RASDs intended to assist in performing surgical tasks, including the placement of certain remotely teleoperated RASDs or autonomous robots used to conduct significant parts of operative procedures independently of qualified practitioners, though some of the recommendations in the guidance may apply to such devices.
The guidance includes a glossary of common terms to ensure regulators and industry work from the same definitions, and a section detailing submission recommendations. FDA notes that, given the broad range of RASDs covered by the guidance, the submission recommendations section does not address specific device types or devices and emphasizes that certain recommendations may not be applicable to the sponsor's specific device.
"For all RASD submissions, you should provide a clear and concise device description that describes all the major functional components of the RASD," said FDA in its recommendation for sponsors providing a device description. "For 510(k) submissions, we recommend you also identify the classification regulation number and product code of your device based on the proposed predicate device.
"The device description should be organized starting with the whole system overview, followed by subassemblies and other components," the agency added.
FDA also noted that sponsors may consider submitting videos demonstrating how their RASDs are used, especially if they include footage of the device user interface and novel technological features. The agency also recommended placing any device features that enhance or augment human capabilities in a separate section that details them.
For sponsors submitting a 510(k) notification, FDA asks that they provide details, including information comparing their RASD to the predicate device. The agency includes a table that illustrates how the information should be presented to demonstrate substantial equivalence (SE).
"When providing the SE comparison information and when writing a narrative analysis, the terms 'identical' or 'same' should only be used for features that are demonstrably identical or the same (i.e., same manufacturer, same design, same materials, same functions)," said FDA. "You should describe any differences in technological characteristics between the subject and predicate devices and provide a rationale as to why the differences do not affect SE to the predicate device.
"Where there are technological differences, your SE analysis should include information demonstrating that the subject device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness," the agency added.
In addition to the RASD, FDA also states that any accessories or compatible devices that are intended to be used with the device should be described in detail in the RASD premarket submission. If the accessory or compatible device already has a marketing authorization, the sponsor is asked to provide the submission number of the accessory or device and demonstrate that it is compatible and interoperable with their RASD, regardless of whether they manufacture the device or if it is manufactured by a third party.
The guidance delves into non-clinical performance testing that the RASD-sponsor should conduct, which evaluates features such as system teleoperation, system controls, kinematics and dynamics, visualization and display systems, and other features. An important part of non-clinical performance testing is assessing the reliability of the RASD over time, including hardware integrity and software stability, and it applies to subassemblies and other components of the device.
"Reliability testing should demonstrate that the system will maintain its integrity over its service life and will not cause harm to the patient due to system or component failure," said FDA, adding that the sponsors should be able to characterize the expected reliability of their device or that the device and its components and accessories will function reliably over the lifespan of the product.
"Reliability testing should demonstrate maintenance of control over surgical instruments and maintenance of the integrity of system information essential to perform surgery over the expected service life or service interval of your RASD," the agency added. "Over the expected service life or service interval of the RASD, you should have objective evidence, with a prespecified and justified acceptance criteria, that surgical instruments will remain under control at all times during use in patients, and that system information essential to perform surgery by qualified practitioners is not degraded to an unacceptable level."
The guidance also includes recommendations for how sponsors should evaluate the software, wireless technology, and cybersecurity aspects of their RASD. The agency noted that adequate software verification and validation, including performance testing, are important to assure regulators that their product operates within safe parameters and functions as intended.
FDA noted that the nature of the software, firmware, and programmable logic may increase the surface area for cyber vulnerabilities and attack vectors. With that in mind, the agency said that sponsors should refer to its cybersecurity guidance, which addresses quality system management and premarket submissions, if their product meets the regulatory definition of a cyber device, and address other cybersecurity considerations.
"Submissions should identify all relevant assets, potential threats, and vulnerabilities on device functionality, end users, and patients, as well as an assessment of exploitability for device vulnerabilities," said FDA. "Based on this analysis, submissions should determine risk levels for identified threats and vulnerabilities and describe suitable mitigation strategies.
"The cybersecurity assessment, including penetration testing, should take into consideration all network elements communicating with the RASD (including all sub-assemblies and other components), accessories, and compatible devices intended to connect to or interact with the system during pre-deployment, normal operation and maintenance," the agency added. "Submissions should identify relevant network elements connected to the RASD."
FDA also emphasized the importance of conducting human factors testing to identify potential use-related hazards and of training qualified operators to operate RASDs safely and effectively. The agency said that manufacturers should develop a validated training program for operators to ensure they have adequate competency before using the devices in clinical settings.
"You should create and deliver an effective training plan for users consistent with the uses being sought for authorization, and provide an overview of the training plan in the premarket submission for your RASD," said FDA. "The training should be comprehensive and should have demonstrated effectiveness in developing device competency for users with varying levels of experience and clinical background.
"The training program and competency expectations should not only focus on surgeons, but also include other OR staff, such as bedside assistants and surgical scrub nurses, who interact with RASDs," the agency added. "For existing RASDs, the need for updates to existing training should be evaluated when changes are introduced to the device user interfaces, including addition of new instruments and new user groups."
The guidance also provides recommendations regarding electrical safety and electromagnetic compatibility (EMC), optical radiation safety, sterility, and reprocessing considerations. It also addresses considerations for evaluating shelf life and packaging, pyrogenicity, biocompatibility, labeling, and in vivo performance.
"An in vivo evaluation of the device performance is important for assessing the safety and effectiveness of the RASD for the uses being sought for authorization," said FDA. "To support authorization of a broad use of the device (e.g., general surgery, gynecology, urology, otolaryngology, or anatomical region) or a more specific use (e.g., colectomy, total radical hysterectomy, radical prostatectomy, transoral robotic surgery (TORS)), in vivo evaluation should demonstrate that the device can reliably function in an operative environment and assist in performing the coordinated maneuvers necessary to complete these surgical procedures."
The draft guidance appendix includes two examples of how sponsors may consider submitting premarket submissions depending on the RASD product.
Stakeholders can comment on the draft guidance on www.regulations.gov under docket no. FDA-2026-N-9505 through 24 November.
