Regulatory comment and research study · In preparation, 2026 · Docket FDA-2026-N-9505 · Research by Kurt E. Sather, API Automations · Clinical co-author to be announced.
Overview
On September 25, 2026 the U.S. Food and Drug Administration issued its first system-level draft guidance for robotically-assisted surgical devices, Robotically-Assisted Surgical Devices — Premarket Submissions (GUI01500081). It sets out what a manufacturer should test and document before a robotic surgical system reaches the market: emergency stops and emergency patient access, motion scaling and tremor filtering, software fault messaging, bedside-assistant training, team-based human-factors validation, and a fixed list of clinical endpoints that includes conversion rate. Public comments close on November 24, 2026.
Comments on device guidance are dominated by manufacturers and trade associations. The surgeons who sit at the console, and the teams at the bedside, rarely comment, and when they do it is seldom with data. This project produces a public comment co-authored by a practicing gynecologic surgeon, in which every recommendation is grounded in federal adverse-event data for gynecologic procedures, and then publishes the analysis behind it.
Why It Matters
The draft guidance identifies the right hazards. It does not yet set a benchmark for how quickly a patient can be reached in an emergency, treat the competency of the bedside team as something to validate rather than describe, or require the post-market reporting fields that would let anyone compute the clinical endpoints it names. Real-world reports for gynecologic robotic surgery, the largest single use of these systems, can show where each of those gaps has consequences. A comment that says so by guidance line number, with a reproducible number beside each claim, is one the reviewing division can act on.
Scope
- Adverse-event surveillance: medical device reports for the four robotic surgical device product codes (NAY, QNM, SAB, SAQ), filtered to gynecologic procedures, coded to the guidance's own hazard categories.
- Clearance and recall history: the 510(k) lineage and recall records for the same product codes.
- Who comments: the composition of public comments on comparable device-guidance dockets, and on this one as it closes.
- Trials and utilization: registered robotic gynecologic trials with posted results, Medicare utilization trends, and manufacturer-reported procedure volumes as the only usable denominator.
- Industry relationships: Open Payments records for the specialty, and for the authors themselves before submission.
Outputs
- The public comment, submitted to docket FDA-2026-N-9505 before the November 24 deadline, structured by guidance section and line number with a proposed text change for each recommendation. Published here once it is a public record.
- A preprint of the full analysis, posted the same week, with the code, the coding schema, the audit sample and the derived dataset released alongside. Linked here by DOI.
- Journal submissions in minimally invasive gynecology and obstetrics and gynecology venues, and a clinical-opinion piece on credentialing and post-market surveillance. Linked here when published.
The methods page describes the pipeline and the coding schema. The results page shows what has been computed from a dated snapshot and nothing else.
Research Team
- Kurt E. Sather, research lead: conception, data, methods, analysis and drafting. Founder of API Automations.
- Clinical co-author, to be announced: a practicing obstetrician-gynecologist and minimally invasive gynecologic surgeon, clinical lead for interpretation and review.
Collaborate
Gynecologic surgeons, bedside teams and professional societies who want to review or co-sign the comment, and institutions interested in serving as review board of record, can reach the research team at contact@apiautomations.com.