Manufacturer Training Programs Became Surgeon Credentialing Boundaries
Robotic harvest of the deep inferior epigastric perforator flap for breast reconstruction illustrates the problem. The dissection involves surgical planes, vessel exposure, energy use, and suturing tasks closely similar to retrorectus dissection in robotic inguinal hernia repair. Surgeons teaching robotic DIEP dissection often use inguinal hernia simulator modules to do it.
A plastic surgeon may nonetheless be unable to obtain manufacturer training for the procedure, because DIEP flap reconstruction is not listed in the device labeling.
What labeling is for
I spent 25 years at FDA, much of it responsible for the regulation of surgical robotic devices.
Device labeling describes the conditions under which a manufacturer may market a device. It reflects the procedure claims a company chose to study, submit, and seek authorization for, shaped by business considerations as much as clinical ones. Under longstanding FDA policy on industry-supported educational activities, a manufacturer cannot provide procedure-specific training outside its authorized labeling. That restriction keeps promotional activity inside the boundaries of what was reviewed, and it is appropriate.
FDA has no authority over hospital privileging. The difficulty arises downstream, where hospitals credentialing surgeons on robotic platforms borrowed manufacturer training courses as their standard. When robotic surgery was unfamiliar and one platform dominated, the manufacturer had the only curriculum and the shortcut made sense.
A boundary drawn around what a company may promote now functions as the boundary of what a surgeon may be trained and privileged to do.
Why now
There are multiple authorized platforms. Residents complete training with substantial robotic experience and documented milestones. Procedures across specialties share anatomy, planes, and maneuvers.
Criteria also vary from institution to institution. Surgeons with privileges at several hospitals routinely describe meeting different robotic requirements at each one. Where standards are set locally against no common reference, demonstrated competence does not travel with the surgeon, and manufacturer courses were at least uniform.
Surgeons excluded by this are already qualified within their specialty. The barrier reflects administrative policy rather than patient risk.
A competency-based alternative
Jesse Selber and I proposed a vendor-neutral, competency-based model in JAMA Surgery this year. It has four parts.
Multiple equivalent on-ramps. Residency and fellowship robotic milestones, society-accredited curricula, independent simulator benchmarks, and documented proctoring all count toward entry. Manufacturer courses become one route among several.
Procedure-agnostic platform safety training. Setup, docking, energy safety, troubleshooting, emergency undocking. This material does not transfer between systems, and manufacturers are well positioned to teach it. Delivered without reference to specific procedures, it remains nonpromotional.
Privileges granted by anatomical domain. Abdominal wall, breast, foregut, transoral, rather than by labeled procedure names. Initial privileges require the safety course, simulator benchmarks, and proctored cases. Maintenance pairs modest annual volume with Ongoing Professional Practice Evaluation, which accredited hospitals already run.
Outcomes assessed with clear denominators. Conversions, complications, reoperations, length of stay, follow-up, and procedure-specific end points, reviewed at intervals by a cross-specialty committee, with predefined triggers for focused review, additional proctoring, or retraining.
This applies to established platforms and procedures with well-characterized risks. Novel platforms, newly enabled procedures, and major device iterations should continue to follow labeled onboarding and vendor-specific training until safety competencies are defined, specialty credentialing boundaries are unchanged, and manufacturer involvement continues in nonpromotional, specialty-agnostic form.
In practice
This model has been implemented at two academic centers, for abdominal-wall and retrorectus procedures, selected reconstructive procedures, and transoral procedures.
Any hospital can adopt it now, with no regulatory change, no new FDA authority, and no legislation. It requires a credentialing committee to decide that its robotic privileging criteria should measure competence rather than course completion.
Course completion is easy to document and competence is harder to assess. That is why the shortcut has lasted, and it is not sufficient reason to keep it.
Binita S. Ashar, MD, MBA, FACS, MAMSE is a board-certified general surgeon and founder of Clarity Surgical Advisors. She served at FDA from 2000 to 2025, most recently as Office Director for Surgical and Infection Control Devices. The full paper, with Jesse C. Selber, MD, MPH, MHCM, appeared in JAMA Surgery on May 13, 2026 (doi:10.1001/jamasurg.2026.1350).
I consult for multiple robotic device manufacturers. Full disclosures are published with the original article in JAMA Surgery.
