FDA issues draft guidance on premarket submissions of robotically-assisted surgical devices

The Food and Drug Administration released draft guidance Sept. 24 that includes recommendations on non-clinical testing, clinical data and labeling for premarket submissions of certain robotically-assisted surgical devices. RASDs are teleoperated systems that assist qualified practitioners with precise positioning and control of one or more surgical instruments to perform open, minimally invasive or endoluminal procedures. The FDA is seeking comments on the draft guidance by Nov. 24 before releasing a final version.