Dive Brief:
- The Food and Drug Administration last week released a draft guidance document spelling out what the agency wants to see in premarket submissions for robotically assisted surgical devices.
- The 50-page document details criteria for system stability and latency, instrument motion and position control, visualization, software, wireless technology, cybersecurity, sterilization, labeling, training and more.
- The agency also said it will hold a two-day public workshop on Dec. 2-3 focused on evaluating the benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities.
Dive Insight:
The FDA’s draft guidance comes as a steady stream of new robotic surgery systems enters the marketplace, many to compete with longtime leader Intuitive.
The agency’s upcoming workshop on robotic devices with remote teleoperation capabilities signals that telesurgery is on the FDA’s radar as more remote procedures are performed globally.
The FDA defines surgical robots as teleoperated, software-controlled systems that have technologies and subassemblies designed to assist clinicians in using instruments to perform open, minimally invasive or endoluminal procedures. Robotic technologies may contain some level of automated functions, the agency said.
Evercore ISI analysts, in a research note, called the draft guidance a positive for the industry because it lays out a specific pathway for FDA approval, compared with a “prior framework that had some ambiguity.” Without a standardized framework, software and cybersecurity in particular can become hurdles, they noted.
The document also helps companies planning to launch newer versions of existing systems by detailing how to show substantial equivalence compared with predicate devices, they said. The guidance provides clarity on specific clinical endpoints for different procedures as well as a pathway for umbrella procedure approval that would cover a more complex procedure within the same category. “This will minimize the clinical evidence burden to some extent,” the analysts wrote.
The FDA is seeking comments on the draft guidance by Nov. 24.
