Use-Related Risk Analysis for Drug, Biological, and Combination Products: Determining Human Factors Study Needs (DRAFT)
This guidance provides recommendations on the purpose and content of a use-related risk analysis (URRA) for drugs, biological products, and combination products. It focuses on how URRA can be used along with other information to determine human factors (HF) data needs during product development and support marketing applications. The guidance primarily applies to drug and biologic-led combination products with device constituent parts, but may also apply to certain standalone drug and biological products.
This is a draft guidance. Not for implementation.
Recommended Actions
- Develop comprehensive URRA early in product development process
- Identify and document all user tasks and potential use errors
- Assess clinical impact and potential harms for each use error
- Categorize tasks as critical or non-critical
- Implement and document appropriate risk controls
- Define evaluation methods for risk controls
- Update URRA throughout product lifecycle
- Use URRA to determine need for HF validation study
- Consider comparative analyses when applicable
- Submit URRA with justification if proposing to not conduct HF validation study
- Use URRA to develop HF validation study protocol if needed
- Engage with FDA early to discuss HF development program
Key Considerations
Human Factors
- URRA should identify all tasks required for product use
- Tasks should be categorized as critical or non-critical
- Critical tasks are those which, if performed incorrectly or not at all, could cause harm
- URRA should be initiated early in development and updated throughout product lifecycle
- URRA should consider all intended uses, potential users, and likely use environments
Labelling
- Labeling should be considered as one aspect of risk control
- Information for safety through labels and labeling should be considered after design controls
- Labeling comparison may be needed when conducting comparative analyses
Safety
- Identify potential use errors and associated harms for each task
- Consider clinical impact of both one-time and repeated use errors
- Implement risk controls to reduce or eliminate risks
- Focus on eliminating risks through device design when feasible
- Consider risk controls in priority order: inherently safe design, protective measures, information for safety
Other considerations
- URRA can be used to justify not submitting HF validation study results
- URRA supports development of HF validation study protocols
- Consider comparative analyses when similar products exist
- Document evaluation methods for risk controls
- Consider use environment factors and user characteristics
Relevant Guidances
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- List of Device Types That Require Human Factors Data in Premarket Submissions (Draft)
- Design Considerations for Medical Devices Intended for Home Use
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ISO 14971: Application of risk management to medical devices
- ISO TR 24971: Guidance on the application of ISO 14971
- ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
Original guidance
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