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The U.S. Food and Drug Administration is announcing a draft guidance, Robotically-Assisted Surgical Devices — Premarket Submissions. This draft guidance, when finalized, provides recommendations on non-clinical testing, clinical data, and labeling to support premarket submissions for certain robotically-assisted surgical devices (RASDs). This guidance does not address remotely teleoperated RASDs, or autonomous robots that perform significant aspects of operative procedures independent of qualified practitioners.
The FDA is also hosting a public workshop on Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities on December 2–3, 2026. The workshop is open to all and will explore a broad range of robotic medical devices both inside and outside the operating room, including those with autonomous and remote teleoperation capabilities.
Together, these opportunities reflect the Center for Devices and Radiological Health's longstanding commitment to advancing safety, effectiveness and innovation of robotic medical devices and engaging with stakeholders as these technologies continue to rapidly evolve.
Note: This draft guidance is not for implementation.
Submit comments on this draft guidance
Submit comments under docket number FDA-2026-N-9505 at www.regulations.gov by November 24, 2026 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this communication, contact CDRH’s Division of Industry and Consumer Education (DICE).
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