Feb 4, 2016

US medical device regulators have specified types of devices for which premarket application submissions should include human factors testing information, according to new Food and Drug Administration guidance.

The FDA guidance explains that devices it identifies warrant human factors data because of “clear potential for serious harm resulting from use error.” Such data is necessary for proper evaluation of safety, effectiveness and substantial equivalence, states the agency.

Premarket applications for the following device types should include human factors testing reports unless applications pertain to the same users, user tasks, interfaces and environments as their predicate devices:

  • Ablation generators
  • Implanted infusion pumps
  • Anesthesia machines
  • Infusion pumps
  • Artificial pancreas systems
  • Insulin delivery systems
  • Auto injectors
  • Negative-pressure wound therapy for home use
  • Automated external defibrillators
  • Robotic catheter manipulation systems
  • Duodenoscopes with elevator channels
  • Robotic surgery devices
  • Gastroenterology-urology endoscopic ultrasound systems with elevator channels
  • Ventilators
  • Hemodialysis and peritoneal dialysis systems
  • Ventricular assist devices

A separate guidance on human factors and usability engineering provides further details on what to include in premarket submissions for these and other device types that may pose serious harm if used incorrectly.




  • Stewart Eisenhart