Findings
HFE/UE is essential for identifying and mitigating use-related risks that could compromise device safety or effectiveness.
Preliminary analyses, such as task and fault tree analyses, help identify critical tasks and use-related hazards early in device development.
Human factors validation testing must represent realistic use scenarios, include diverse user populations, and focus on critical tasks with potential for serious harm.
Residual risks that remain after validation testing must be justified in terms of the device’s overall benefits and risk management measures.
Effective risk management prioritizes design modifications over labeling or training as the primary method for addressing use-related hazards.

Recommendations
Incorporate HFE/UE into all stages of device development to address use-related hazards through design improvements.
Conduct comprehensive risk analyses to identify and prioritize critical tasks that may lead to serious harm if performed incorrectly.
Design human factors validation testing to reflect real-world conditions and involve representative user populations.
Address use-related risks primarily through design modifications, with labeling and training as secondary measures.
Submit detailed HFE/UE documentation in premarket applications to facilitate FDA review and approval.

Regulatory Considerations
Submit human factors validation testing data as part of premarket applications for devices where use-related errors could result in serious harm.
Risk management processes must align with standards such as ANSI/AAMI/ISO 14971 and IEC 62366, ensuring comprehensive hazard identification and mitigation.
Conduct additional validation testing if modifications to a marketed device impact user interactions or introduce new risks.
For actual-use testing, ensure compliance with Investigational Device Exemption (IDE) requirements where applicable.
Manufacturers should maintain detailed records of HFE/UE processes, which must be available for FDA review upon request.