Human Factors Studies and Related Analyses for Combination Products
This guidance focuses on the application of Human Factors Engineering (HFE) principles to combination products comprised of a medical device combined with a drug or biological product. It covers key aspects like defining combination product critical tasks, considerations for drug-device constituent parts used together, training requirements, and human factors validation data needed for premarket submissions. The guidance does not address HF considerations for generic drug applications (ANDAs), biosimilars, label comprehension studies for non-prescription uses, or when HF studies are subject to human subject protection requirements.
Recommended Actions
- Conduct comprehensive URRA early in development to identify critical tasks and risks
- Plan iterative formative HF evaluations throughout development process
- Determine if training will be part of user interface and validate training program if required
- Conduct HF validation study with final finished combination product or justify use of representative product
- Submit draft HF validation protocol and labeling for FDA review before conducting validation study
- Request early discussions with FDA regarding HF program and development strategy
- Consider drug properties’ impact on user interactions in risk analysis
- Analyze any residual risks after HF validation and determine if additional modifications needed
- Update URRA and conduct additional HF validation as needed for product modifications
- Submit comprehensive HF report in marketing application documenting entire HF process
Key Considerations
Clinical testing
- HF actual-use validation studies may be needed when product use, environments or aspects are complicated/poorly understood
- Clinical studies for safety and effectiveness are different from HF validation studies and serve different purposes
- HF information/data may be needed before initiating clinical investigations to protect subject safety
Human Factors
- Must conduct comprehensive Use-Related Risk Analysis (URRA) to identify critical tasks
- HF validation studies should be conducted with final finished combination product
- Training program must be validated if it’s part of user interface requirements
- Formative HF evaluations should be conducted iteratively throughout development
- Consider user population characteristics, limitations and use environment
Labelling
- Comprehensive labeling review needed when submitted with HF validation protocol
- Labeling is part of the user interface and should be evaluated in HF validation
Safety
- Must consider medication error risks and potential harm to patients/users
- Critical tasks are those that could cause harm if performed incorrectly
- Residual risks after HF validation must be thoroughly analyzed
Other considerations
- Drug properties can affect user interactions and should be considered in risk analysis
- Design changes require updated URRA and potential additional HF validation
- Early discussions with FDA recommended regarding HF program
Relevant Guidances
- 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)
- Current Good Manufacturing Practice Requirements for Combination Products
- Premarket Review Pathways for Combination Products
- Postmarketing Safety Reporting Requirements for Combination Products
Related references and norms
- 21 CFR 820.30: Design Controls
- 21 CFR Part 4: Current Good Manufacturing Practice Requirements for Combination Products
Original guidance
This post is licensed under CC BY 4.0 by the author.