List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)
This guidance identifies medical device types that require human factors data in premarket submissions (PMA, 510(k)) due to their potential for serious harm resulting from use errors. It provides clarity on FDA's expectations regarding human factors testing submissions.
This is a draft guidance. Not for implementation.
Recommended Actions
- Review if your device is on the priority list for human factors review
- If listed, prepare human factors test report following FDA guidance format
- If not submitting human factors data for a listed device, prepare detailed justification
- For non-listed devices, conduct risk analysis to determine if human factors data is needed
- Consider additional triggers that might require human factors data even for non-listed devices
- Ensure human factors testing is integrated into design control process
- Document all human factors related decisions and rationales
- Consider consulting with FDA if unclear about human factors data requirements
Key Considerations
Human Factors
- Human factors data must be submitted for specific listed devices (e.g., ablation generators, anesthesia machines, artificial pancreas systems, etc.)
- A human factors test report should follow the format described in “Applying Human Factors and Usability Engineering to Medical Devices”
- If no human factors data is submitted, a detailed rationale must be provided explaining why it’s not necessary
- For non-listed devices, human factors data is required if risk analysis shows potential serious harm from use errors
Other considerations
- Human factors data may be required for non-listed devices in specific cases:
- PMA or De Novo Petition submissions with potential serious harm
- Modified user interface to meet special controls
- Change in intended users (e.g., from healthcare professionals to lay users)
- History of recalls/adverse events related to use errors
- Device modifications affecting user interface, tasks, potential harm, or use environment
Relevant Guidances
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
Related references and norms
- No specific norms or standards are referenced in this guidance
Original guidance
- List of Device Types That Require Human Factors Data in Premarket Submissions
- HTML / PDF
- Issue date: 2016-02-03
- Last changed date: 2019-05-14
- Status: DRAFT
- Official FDA topics: Medical Devices, Errors, Postmarket, and Problems, Premarket Approval (PMA), Labeling, Premarket, Investigational Device Exemption (IDE), Safety - Issues
- ReguVirta summary file ID: afabde7181e52efc186834b9c9e57091
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