FDA Guidances: UDI, Human Factors Evaluation – Drug and Device Digest

FDA Brief: Week of Feb 1, 2016


fda guidances


  • Medical devices eligible for reimbursement labeled with an 11-digit reimbursement number – National Health Related Item Code (NHRIC) or National Drug Code (NDC) number
  • The Unique Device Identification System final rule (UDI Rule) includes provision that rescinds any NHRIC or NDC number
  • Draft guidance communicates
    • Intent not to enforce before September 24, 2021
    • Continued use of FDA labeler codes until September 24, 2018



human factors

  • Guidance on appropriate human factors and usability engineering processes for safe and effective use – users, uses, use environment
  • Improve device design to minimize potential use errors and resulting harm
  • Risk Management by eliminating or reducing design-related problems

Guidance describes :

  • Device Users, Use Environments and User Interface
  • Preliminary Analyses and Evaluations
  • Elimination or Reduction of Use-Related Hazards
  • Human Factors Validation Testing
  • Documentation





  • Requirement of human factors data in premarket submissions based on potential for serious harm due to use error
  • LISTED (for PMA, 510(k)) : Ablation generators, Anesthesia machines, Artificial pancreas systems,  Auto injectors,  Automated external defibrillators,  Duodenoscopes,  Gastroenterology-urology endoscopic ultrasound systems, Hemodialysis and peritoneal dialysis systems, Infusion pumps, Insulin delivery systems, Negative-pressure wound therapy, Robotic catheter manipulation systems, Robotic surgery devices, Ventilators,  Ventricular assist devices
  • NOT LISTED (for PMA, De Novo): Risk assessment on case-by-case basis; include criteria such as User interface modification, Different users, Recalls, adverse events, and problem reports, Device modifications



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