FDA Finalizes Updated Device Human Factors Guidance
FDA has issued an updated final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices,” which describes current recommendations for applying human factors and usability engineering during the design and development of medical devices, revising a 2016 document to reflect changes in quality system requirements and current regulatory expectations. The document s intended to help manufacturers design devices that minimize use errors and improve patient safety.
The revised guidance emphasizes that manufacturers should integrate human factors engineering throughout the product development process, with particular attention to device user interfaces, including displays, controls, labeling, packaging and instructions for use. FDA says the objective is to identify and reduce use-related hazards that could compromise medical treatment or cause patient harm by incorporating human factors considerations into risk management and device design from the outset.
Among the most significant updates is the guidance's alignment with FDA's Quality Management System Regulation (QMSR), which took effect in February and harmonized device quality system requirements with ISO 13485:2016. The guidance notes that manufacturers should incorporate outputs from their risk management processes into device design and usability requirements, reflecting the agency's broader transition to internationally harmonized quality management standards.
FDA reiterates that manufacturers should identify "critical tasks" — those that, if performed incorrectly or omitted, could result in serious harm — and evaluate foreseeable use errors through analytical methods such as failure mode effects analysis, fault tree analysis, task analysis, expert reviews and formative usability studies. The agency recommends modifying device design to eliminate or reduce hazards whenever possible, rather than relying primarily on labeling or user training, which it considers less effective risk controls.
The guidance also outlines FDA's expectations for human factors validation testing before marketing submission. Validation studies should use representative users, realistic use environments and the final device design to demonstrate that intended users can safely perform all critical tasks without serious use errors. FDA generally recommends at least 15 participants from each distinct user population included in validation testing and encourages manufacturers to seek agency feedback on proposed testing protocols through the Q-Submission program before conducting pivotal human factors studies.