www.fdanews.com/articles/169078-infusion-pump-final-guidance-targets-poor-safety-profile
Infusion Pump Final Guidance Targets Poor Safety Profile
December 12, 2014
The FDA is ratcheting up safety controls on infusion pumps, mandating that developers of new pumps follow stricter requirements for design validation and verification and provide more detailed applications to address safety hazards associated with pumps used in the home.
Devices & Diagnostics Letter