Draft Guidance for Industry and Food and Drug Administration Staff

Applying Human Factors and Usability Engineering to Optimize Medical Device Design

DRAFT GUIDANCE
Document issued on: June 22, 2011

Table of Contents

  • 1. Introduction
  • 2. Scope
  • 3. Overview
  • 4. Regulations, Guidance Documents, and Standards for HFE/UE
  • 5. Device Users, Use Environments and User Interfaces
    • 5.1 Device Users
    • 5.2 Device Use Environments
    • 5.3 Device User Interfaces
  • 6. Analytical Methods for Identifying, Evaluating and Understanding Use-Related Hazards
    • 6.1 Identification of Known Problems
    • 6.2 Analytical Approaches to Hazard Identification and Task Prioritization
      • 6.2.1 Contextual Inquiry
      • 6.2.2 Interviews and Focus Groups
      • 6.2.3 Function and Task Analysis
      • 6.2.4 Heuristic Analysis
      • 6.2.5 Expert Review
  • 7. Formative Evaluations
    • 7.1 Cognitive Walk-Through
    • 7.2 Simulated Use Testing
  • 8. Mitigation and Control of Use-Related Hazards
  • 9. Design Verification Testing
  • 10. Human Factors Validation Testing
    • 10.1 Simulated Use Validation Testing
      • 10.1.1 Tasks and Use Scenarios
      • 10.1.2 Test Participants (Subjects)
      • 10.1.3 Participant Training
      • 10.1.4 Data Collection
      • 10.1.5 Interpretation of Validation Test Results and Addressing Problems
    • 10.2 Clinical Validation Testing
  • 11. Documentation
  • 12. Conclusion
  • Appendix A
  • Appendix B
  • Appendix C

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