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.
What You Need to Know? 👇
What is the difference between medical device patient labeling and professional labeling?
Medical device patient labeling is information targeted to patients or lay caregivers in understandable language, while professional labeling is for healthcare practitioners. Patient labeling translates professional information into lay language without altering the intent of indications, contraindications, warnings, or precautions.
When is medical device patient labeling required by FDA?
Patient labeling should be supplied whenever it can benefit patients or lay caregivers by increasing their knowledge about the device. It’s essential for devices operated by lay users and when patients need risk/benefit information to make informed decisions about device use.
What reading level should medical device patient labeling target?
Medical device patient labeling should be written at an eighth-grade reading level or below to reach most of the population. For elderly or visually impaired users, consider using at least 14-point font size and ensure clear, simple language throughout.
What are the key elements of effective warnings and precautions in patient labeling?
Effective warnings and precautions must include four elements: a signal word (WARNING/CAUTION), hazard avoidance directive, clear statement of the hazard nature, and consequences of non-compliance. They should be concise, conspicuous, and placed contextually within relevant procedures.
How should manufacturers pretest medical device patient labeling?
Manufacturers should conduct systematic pretesting using methods like focus groups, individual interviews, usability testing, or self-administered questionnaires with target audiences. This helps identify comprehension issues, organizational problems, and ensures the labeling effectively communicates safety and usage information.
What distribution methods should be considered for patient labeling?
Consider timing of delivery, whether intermediaries are involved, potential logistical difficulties, and obstacles to reaching patients. Web-based distribution can provide up-to-date information. During pretesting, ask target audiences about preferred distribution methods and assess their past experiences.
What You Need to Do 👇
Recommended Actions
- Identify target audience and their informational needs
- Determine appropriate content based on device type:
- Risk/benefit information
- Instructions for use
- Or both
- Develop draft labeling following guidance recommendations for:
- Content organization
- Language and readability
- Formatting and graphics
- Warnings and precautions
- Conduct pretesting with target audience:
- Individual interviews
- Focus groups
- Usability testing
- Readability assessment
- Revise labeling based on pretest results
- Implement distribution method to ensure labeling reaches users
- Monitor effectiveness and update as needed based on user feedback
- 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
- Consider distribution method to ensure labeling reaches users
- Include date of printing
- Make user assistance information easily accessible
- Consider international/travel use if applicable
- Include warranty information if applicable
Relevant Guidances 🔗
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- List of Device Types That Require Human Factors Data in Premarket Submissions (Draft)
Related references and norms 📂
- ANSI Z535.4-1998: American National Standard for Product Safety Signs and Labels