What changed
FDA issued the draft guidance Robotically-Assisted Surgical Devices — Premarket Submissions on September 25, 2026. It provides non-binding recommendations for certain robotically-assisted surgical device (RASD) premarket submissions, including device description, non-clinical performance testing, software, cybersecurity, human factors, clinical data, and labeling. FDA states that the guidance is for comment and is not for implementation. Comments should be submitted by November 24, 2026, under docket FDA-2026-N-9505.
The recommendations may be relevant across premarket pathways depending on the device and submission. They do not replace device-specific statutory or regulatory requirements, and FDA notes that some recommendations may not apply to a particular device.
The scope is narrower than the broader surgical-robotics category
The draft defines RASDs as teleoperated, software-controlled systems used under the direct control or supervision of a qualified practitioner. Its scope includes systems for open, minimally invasive, and endoluminal procedures. In this guidance, endoluminal use does not include positioning and controlling multiple devices through blood vessels or another intravascular approach.
The draft does not address remotely teleoperated RASDs or autonomous robots that perform significant aspects of an operative procedure independently. FDA says some recommendations may still be relevant to out-of-scope systems and recommends Q-Submission engagement when manufacturers need device-specific feedback.
Submission recommendations connect system design to evidence
FDA recommends describing the complete system, then its subassemblies and components. Examples include the system’s principle of operation, kinematic and connection diagrams, data transmission, physical dimensions, working-arm movement and force characteristics, emergency stops, and emergency patient-access procedures.
The non-clinical recommendations cover teleoperation, system controls, kinematics and dynamics, visualization, device-specific features, and reliability. FDA recommends testing components and the complete system, including compatible devices and accessories, under conditions representative of worst-case clinical use. The draft also addresses software, cybersecurity, training, human factors, electrical safety, sterility, reprocessing, biocompatibility, in vivo evaluation, clinical data, and labeling.
For labeling, FDA recommends that intended procedures, patient selection, emergency instructions, and learning-curve information align with the evidence submitted. The draft does not establish a blanket requirement for a separate clinical study for every procedure.
What companies can check
- Compare the draft’s device-description recommendations with the information planned for the submission, including system architecture, arm characteristics, safety features, and emergency access.
- Review whether verification and validation cover both subassemblies and the complete system under justified worst-case conditions.
- Check traceability across software requirements, testing, unresolved anomalies, and risk controls; assess section 524B obligations for devices that meet the statutory definition of a cyber device.
- Review human-factors evidence for representative operating-room tasks, users, configurations, and emergency scenarios.
- Check whether labeling and procedure claims match the supporting non-clinical and clinical evidence.
- Consider submitting comments under docket FDA-2026-N-9505 by November 24, 2026.
These are MedTech Current’s practical review suggestions based on the draft. The guidance remains non-binding while in draft form.
Sources
- Primary official sourceRobotically-Assisted Surgical Devices - Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceRobotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (opens in a new tab)U.S. Food and Drug Administration