On September 25, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance that sets out the agency’s recommendations on nonclinical testing, clinical data, and labeling for premarket submissions involving certain robotically assisted surgical devices (RASDs). The FDA is accepting comments through November 24, 2026. Like all draft guidance, the document is not binding on the FDA or the public. The draft describes RASDs as teleoperated, software-controlled systems that assist qualified practitioners in positioning and controlling surgical instruments during open, minimally invasive, or endoluminal procedures.
The scope of the draft guidance is narrower than the term “robotic surgery” might suggest. It excludes pre-operative planning and stereotaxic systems, which the FDA does not consider as RASDs, along with RASDs used to place or operate interventional devices such as catheters. The draft guidance also does not address remotely teleoperated systems or autonomous robots that perform significant aspects of operative procedures independently of qualified practitioners. These exclusions limit the reach of the draft guidance and do not exempt any device from FDA oversight. The FDA notes that certain recommendations may still be relevant to excluded devices and strongly encourages their manufacturers to seek feedback through the Q-Submission Program.
One of the more consequential features for submission planning is the proposed “umbrella and covered procedure” paradigm. Under this approach, performance data from a procedure of higher complexity and risk may support authorization for procedures of lesser complexity and risk within the same surgical specialty, and additional in vivo data for the covered procedure may not be needed. The FDA recommends that sponsors seeking 510(k) marketing authorization for multiple procedures list each procedure in the indications for use statement, or in proposed labeling that the statement references. According to Appendix A, covered procedures generally share identical or similar steps with the umbrella procedure, and the examples provided do not establish that extrapolation will be appropriate in every case. For sponsors pursuing broad indications, the central question is whether the selected umbrella procedure adequately represents each specific use, not simply whether the same platform can perform it.
The draft guidance also draws a line between evidence of surgical performance and evidence about the treatment of an underlying disease. It states that clinical data are often needed for RASDs that have not previously been authorized in the United States. For modifications to authorized systems, the FDA may request clinical data in several circumstances, including new indications, different technology, and specific performance claims such as superiority or treatment of a particular disease or condition. The surgical endpoints the FDA generally recommends, such as conversion rate, adverse events, readmission, and operative time, measure procedural performance rather than disease outcomes. Where applicable, the draft guidance further recommends labeling stating that disease-treatment outcomes were not evaluated as part of the authorization.
Manufacturers would benefit from aligning proposed indications, study endpoints, and promotional claims early in development. Data showing that a system can complete a procedure safely do not, on their own, support claims about disease outcomes. The FDA has previously stated that it has not authorized any RASD specifically for the prevention or treatment of cancer, which makes this distinction especially relevant to marketing materials for oncologic procedures. Sponsors planning multi-procedure submissions may also wish to comment on the umbrella paradigm and the recommended endpoints before the comment period closes.