Human factor is a term used to describe the application of the knowledge of human abilities and limitations to the design of medical devices. Why is the FDA concerned with studies of human factors? Human factors influence the safety and efficacy of a device. Failures in the use of medical devices are often not the fault of the device itself but how humans interact with it. Addison Whitney’s center for regulatory guidance series it’s not that complicated looks behind the curtain, and breaks down the common questions and challenges around gaining regulatory approval.