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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.

  1. Conduct comprehensive URRA early in development to identify critical tasks and risks
  2. Plan iterative formative HF evaluations throughout development process
  3. Determine if training will be part of user interface and validate training program if required
  4. Conduct HF validation study with final finished combination product or justify use of representative product
  5. Submit draft HF validation protocol and labeling for FDA review before conducting validation study
  6. Request early discussions with FDA regarding HF program and development strategy
  7. Consider drug properties’ impact on user interactions in risk analysis
  8. Analyze any residual risks after HF validation and determine if additional modifications needed
  9. Update URRA and conduct additional HF validation as needed for product modifications
  10. 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

  • 21 CFR 820.30: Design Controls
  • 21 CFR Part 4: Current Good Manufacturing Practice Requirements for Combination Products

Original guidance

  • Human Factors Studies and Related Analyses for Combination Products
  • HTML / PDF
  • Issue date: 2023-09-07
  • Last changed date: 2023-09-07
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: 62fc0c3f11de0cf08c13da0bbcde836c
This post is licensed under CC BY 4.0 by the author.