The FDA’s Center for Devices and Radiological Health has issued a draft guidance for robotically assisted surgical devices (RASDs), addressing the content of premarket submissions for these products. However, the agency has also scheduled a public meeting to consider robotic surgery systems with autonomous or remote teleoperation capabilities, an evolution of RASD systems that may challenge conventional regulatory oversight.
Robotic surgical systems first appeared in the U.S. in 1992 when a medical center in Sacramento, Calif., hosted a hip
The draft provides manufacturers with recommendations for non-clinical and clinical testing of RASDs, which are described as teleoperated, software-controlled systems. The draft clarifies that the systems that are within the scope of the draft guidance are those which are under the direct control or supervision of a qualified practitioner. Interventional catheters that might be described as RASDs designed to assist in performing surgical tasks, such as placement or use of interventional devices, are not within the scope of the draft.
The scope of the draft is also exclusive of remotely teleoperated systems and autonomous robotic systems. However, the agency states that some of the draft’s recommendations may be relevant for these systems. The draft provides some definitional context, describing remote teleoperation as the use of a console that is not located in the same operating room as the bedside/patient subassembly. Remote operation may imply “variable distances” between the console and these other components. Local teleoperation describes placement of the console in the same operating room as the bedside/patient subassembly.
CDRH will hold a Dec. 2-3, 2026, workshop on autonomous and remote teleoperation RASDs, which can be attended in person or virtually. The workshop will include discussions of questions such as terminology and key technical considerations. Other discussions will delve into the probable benefits and risks associated with autonomous and/or remote teleoperation capabilities. The workshop will also explore considerations for future policy development that address innovations in this technological area, including those that are in development but not yet in commercial distribution. Registration is required for both in-person and virtual attendance.
Other agencies at the Department of Health and Human Services are engaged in this space as well. The Advanced Research Projects Agency for Health (ARPA-H) announced Aug. 6 that it has provided grants for development of autonomous robotic surgical systems. ARPA-H will provide as much as $175.3 million in grants over five years for development of endovascular robots for treatment of stroke and microrobots for debulking and debris removal for treatment of ischemic stroke. The agency stated that Autonomous Interventions and Robotics (AIR) program may revolutionize these procedures in that these systems will be able to perform their tasks without direct human input.