List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)

This is a draft guidance. Not for implementation.

What You Need to Know? 👇

What devices require human factors data in FDA premarket submissions?

The FDA has identified 16 high-priority device types including infusion pumps, ventilators, robotic surgery devices, anesthesia machines, and artificial pancreas systems that must include human factors data unless no changes are made to users, tasks, interfaces, or environments.

When is human factors testing required for devices not on the priority list?

Human factors data is required when risk analysis indicates potential for serious harm from use errors, or for PMAs/De Novo petitions with use error risks, user interface modifications, different intended users, or devices with recall histories attributed to use errors.

What should be included in a human factors submission to FDA?

Submissions should include a comprehensive human factors report summarizing usability engineering processes, preliminary analyses, evaluations, validation testing results, and conclusions as described in FDA’s “Applying Human Factors and Usability Engineering to Medical Devices” guidance document.

Can manufacturers avoid human factors testing for priority devices?

Yes, but only with a detailed rationale demonstrating through risk analysis that the severity of potential harm from use errors is not serious. This requires thorough documentation of users, uses, and use environments analysis.

What triggers human factors requirements for device modifications?

Modifications requiring human factors data include user interface changes (even simplifications), added/changed user tasks, increased harm severity from use errors, or new use environments like home settings, provided the device has serious harm potential.

How does FDA determine which devices need human factors review?

FDA’s determination is based on Medical Device Reporting (MDR) data, recall information showing clear potential for serious harm from use errors, and case-by-case analysis considering submission type, user changes, interface modifications, and adverse event history.

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What You Need to Do 👇

Recommended Actions

1. Review if your device is on the priority list for human factors review
2. If listed, prepare human factors test report following FDA guidance format
3. If not submitting human factors data for a listed device, prepare detailed justification
4. For non-listed devices, conduct risk analysis to determine if human factors data is needed
5. Consider additional triggers that might require human factors data even for non-listed devices
6. Ensure human factors testing is integrated into design control process
7. Document all human factors related decisions and rationales
8. 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

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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

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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 ID: afabde7181e52efc186834b9c9e57091