Tag: User Error

21
Apr

Improving Awareness of the Importance of Human Factors

Awareness Is Important FDA recently issued draft guidance entitled “List of Highest Priority Devices for Human Factors Review,” informing medical device manufacturers which device types should have human factors data included in premarket submissions (i.e., for PMA or 510(k)). According to the guidance, it seems that FDA believes these device types have clear potential for serious harm resulting from use error, and that

Read more