FDA Updates Landmark Human Factors Guidance for Medical Devices

On Aug. 3, 2026, the U.S. Food and Drug Administration (FDA) released an updated final version of its widely used guidance, Applying Human Factors and Usability Engineering to Medical Devices, marking the first revision since the guidance was issued in 2016. While the update does not fundamentally change the FDA's expectations for applying human factors engineering (HFE) during device development or conducting human factors validation testing, it modernizes the document to align with current regulatory frameworks, including the FDA's Quality Management System Regulation (QMSR), ISO 13485:2016, ISO 14971:2019 and IEC 62366-1.  

The most notable updates involve the harmonization of terminology and definitions. The FDA expanded the definitions section to incorporate concepts such as harm, normal use, residual risk, serious harm, serious injury and use-related risk analysis (URRA). It also revised existing definitions to align more closely with current international standards. Throughout the guidance, the FDA replaces the older term "risk management measures" with "risk control measures," the terminology used in ISO 14971, reinforcing the integration of HFE activities into contemporary risk management processes. Importantly, the FDA's core expectations remain unchanged, including its focus on identifying critical tasks, reducing use-related risks through design to the extent possible and conducting robust human factors validation testing with representative users from each distinct user population.  

Another notable change is the removal of the former Appendix A, which provided a sample human factors/usability engineering report structure for regulatory submissions. Instead, Section 9, Documentation, now directs manufacturers to the FDA's separate guidance, Content of Human Factors Information in Medical Device Marketing Submissions, as the primary source for understanding what HFE information should be included in a premarket submission. Overall, the 2026 update is best viewed as a clarification and harmonization effort rather than a policy shift, bringing the FDA's HFE guidance into greater alignment with current quality management system, risk management and usability engineering standards. 

For more information about the new human factors content guidance issued in May 2026, watch the recording of our July 28 webinar and contact our team to discuss your human factors needs.