Regulate Robotic Surgery Devices By Function, Not Indication, Stakeholders Tell FDA
This article was originally published in The Gray Sheet
Executive Summary
Industry and physicians speaking at a two-day FDA meeting on robotically-assisted surgical devices emphasized the need to regulate the technology as any other surgical tool, with Intuitive Surgical proposing a new regulatory paradigm to accomplish that. Meanwhile, the company and surgeons differ on who should be leading physician training on the robotic systems.