Product Development
FDA expects manufacturers to systematically address use-related risks before submission. Human factors engineering is not a usability checkbox — it is an iterative process of identifying how users can misuse a device and designing the interface to prevent it.
Plan Your HFE ProgramHFE Program Design
FDA's 2016 guidance "Applying Human Factors and Usability Engineering to Medical Devices" establishes the framework FDA reviewers use to evaluate HFE submissions. The guidance outlines a development process that begins with preliminary analysis — intended users, intended use environments, and user interface characterization — and proceeds through iterative formative studies to a summative usability study conducted on the final design with representative users performing critical tasks.
FDA does not require a summative usability study for every device. The requirement for a summative study is driven by the presence of critical tasks — tasks where use error could cause or contribute to serious harm. For devices where all tasks are low-risk, a comprehensive use-related risk analysis and formative evaluation documentation may suffice. Determining which threshold applies to your device requires analysis of the intended use, the criticality of user tasks, and comparable submissions for the device type. We make this determination at the start of the HFE program to right-size the evaluation effort.
The use-related risk analysis (URRA) is the systematic analysis of how users can err in using the device and what the consequences of those errors would be. The URRA identifies user tasks, the possible use errors for each task, the hazardous situations those errors could create, and the severity of potential harm. It is the connection between the design of the user interface and the risk management file — use errors identified in the URRA should be addressed through interface design changes or mitigations, and residual risks should be documented and accepted through the risk management process.
The URRA is a living document that evolves as the design evolves. When formative studies reveal new use error patterns, the URRA is updated to reflect them. This creates an auditable record of how the HFE program identified risks and how the design responded to them — which is what FDA reviewers want to see in the HFE report.
The summative usability study is the formal evaluation that demonstrates the final design can be used safely and effectively by representative users without training beyond what will be provided at launch. Study design requires: identification of user groups, selection of representative users, definition of critical and essential tasks, a realistic simulated use environment, a structured observation protocol, and decision criteria for determining whether the study passes.
FDA reviewers look for specific elements when reviewing summative studies: was the user population representative, were all critical tasks tested, were use errors observed and their root causes analyzed, were any critical task failures addressed before submission, and does the overall pattern of use errors demonstrate acceptable residual risk? We design and conduct summative studies to this standard and write the HFE report in the format FDA expects.
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Use-related risk is one of the most common sources of FDA Additional Information requests in 510(k) reviews. We build HFE programs that anticipate FDA's questions and answer them before the submission is filed.