By Carol Barnum
•
March 13, 2025
What Is human factors validation? Human factors validation focuses on assessing how intended users interact with a medical device under expected conditions in simulated use. The FDA requires this process to confirm that the device can be used safely and effectively by the intended users without causing harm or errors. It’s not about making assumptions—validation involves carefully designed usability tests where actual users perform critical tasks with the device. Their performance and any issues that arise form the basis for confirming that the device can be used safely and effectively by the intended users or if improvements are needed to the product’s design. If an iterative process has been used leading up to summative human factors validation testing, the results are more likely to confirm that users can safely use the device.