FDA draft guidelines for Robotically-Assisted Surgical Devices

 

FDA released a draft guidance for robot-assisted surgery devices. It is under public commenting until November 24.

"This draft guidance document provides recommendations on non-clinical testing, clinical data, and labeling to support premarket submissions for certain robotically-assisted surgical devices (RASDs). RASDs are teleoperated, software-controlled systems that integrate robotic technologies and subassemblies that are designed to assist qualified practitioners in precisely positioning and controlling one or more surgical instruments to safely and effectively perform open, minimally invasive, or endoluminal procedures. The recommendations reflect FDA’s current thinking for these devices and are intended to promote consistency and facilitate efficient review of RASD submissions." 

Source: FDA