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Human Factors Information Needed in Medical Device Marketing Submissions (DRAFT)

This guidance provides a risk-based framework to determine what human factors (HF) information should be included in medical device marketing submissions to FDA (510(k)s, De Novo requests, PMAs, PMA supplements, and HDE applications). It does not describe how to perform HF evaluations or when a marketing submission is required.

This is a draft guidance. Not for implementation.

  1. Determine appropriate HF Submission Category using the flowchart and decision points
  2. Conduct use-related risk analysis to identify critical tasks
  3. Document intended users, uses, and use environments
  4. Describe device user interface and any modifications
  5. Analyze and document use-related hazards and risks
  6. Implement and validate risk mitigation measures
  7. Prepare appropriate HF documentation based on submission category
  8. Include rationale for residual risks
  9. Maintain complete HF documentation in design history file
  10. Submit required HF information in marketing submission based on category

Key Considerations

Human Factors

  • Use a risk-based approach to determine HF Submission Category (1, 2, or 3)
  • Identify presence of or modifications to critical tasks
  • Provide appropriate level of HF information based on category:
    • Category 1: Conclusion and high-level summary
    • Category 2: Rationale for no critical tasks
    • Category 3: Full HF engineering report with validation testing

Labelling

  • Include copies of labeling provided to users
  • Document changes to labeling when modifying existing devices
  • Describe training materials when applicable

Safety

  • Identify and analyze use-related hazards and risks
  • Document risk mitigation measures
  • Provide rationale for acceptable residual risks

Other considerations

  • ANSI/AAMI/IEC 62366-1:2015+AMD1:2020: Medical devices—Part 1: Application of usability engineering to medical devices
  • ANSI/AAMI/ISO 14971:2019: Medical devices—Application of risk management to medical devices
  • ANSI/AAMI HE75:2009/(R)2018: Human factors engineering - Design of medical devices

Original guidance

  • Human Factors Information Needed in Medical Device Marketing Submissions
  • HTML / PDF
  • Issue date: 2022-12-09
  • Last changed date: 2022-12-08
  • Status: DRAFT
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 7703ff790338553a72742d1b9c8ed5f2
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