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Writing Medical Device Patient Labeling: Content and Design Considerations

This guidance provides recommendations for manufacturers and FDA reviewers on developing and evaluating medical device patient labeling to make it understandable and usable by patients or lay caregivers. It covers both risk/benefit information and instructions for use that should be included in patient labeling.

  1. Identify target audience and their informational needs
  2. Determine appropriate content based on device type:
    • Risk/benefit information
    • Instructions for use
    • Or both
  3. Develop draft labeling following guidance recommendations for:
    • Content organization
    • Language and readability
    • Formatting and graphics
    • Warnings and precautions
  4. Conduct pretesting with target audience:
    • Individual interviews
    • Focus groups
    • Usability testing
    • Readability assessment
  5. Revise labeling based on pretest results
  6. Implement distribution method to ensure labeling reaches users
  7. Monitor effectiveness and update as needed based on user feedback
  8. Maintain consistency with professional labeling while ensuring lay comprehension

Key Considerations

Non-clinical testing

  • Pretesting of labeling with target audience before final version
  • Usability testing to determine if labeling enables safe and effective device use
  • Testing readability level (should be 8th grade or below)

Human Factors

  • Consider target audience characteristics (age, disabilities, etc.)
  • Consider use environment
  • Evaluate comprehension through user testing
  • Use clear organization, formatting and graphics to enhance usability

Labelling

  • Include key sections: Table of Contents, Glossary, Device Description, Indications, Contraindications, Warnings/Precautions, Operating Instructions, Troubleshooting, etc.
  • Use clear, simple language at 8th grade reading level or below
  • Include graphics and illustrations to enhance understanding
  • Format text for readability (12+ point font, white space, etc.)
  • Group similar information together
  • Place warnings before associated tasks
  • Include user assistance information

Safety

  • Include clear warnings and precautions with:
    • Signal words (WARNING, CAUTION)
    • Hazard avoidance directives
    • Nature of hazard
    • Consequences of not following instructions
  • Place warnings before associated tasks
  • Prioritize by clinical significance

Other considerations

  • ANSI Z535.4-1998: American National Standard for Product Safety Signs and Labels

Original guidance

  • Writing Medical Device Patient Labeling: Content and Design Considerations
  • HTML / PDF
  • Issue date: 2001-04-19
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Labeling
  • ReguVirta summary file ID: 7965e9247a7771aaf31c38ba5ae00198
This post is licensed under CC BY 4.0 by the author.