Medical devices rely on proper use to be "safe and effective"

Medical devices rely on proper use to be "safe and effective," which is why FDA has in recent years encouraged devicemakers to incorporate human factors engineering into their development processes. What is human factors engineering (or HFE)? FDA defines the term, simply, as the "application of human factors principles to the design of devices and systems." HFE is accounting for how users interact with a device, and the process of identifying operational or label issues that may prevent the device from being used as intended. FDA often requires that human factors data be included in premarket submissions, or the data may be reviewed in postmarket scenarios in response to a serious adverse event. Read the article ...