humanitarian device exemption


humanitarian device exemption

(hu-man?i-ter'e-an),

HDE.

Legal permission from the FDA to a manufacturer of a new medical device granting it a waiver from some of the usual requirements in order to expedite introduction of the device into clinical use. HDEs are granted for devices that treat rare diseases for which it would be impractical or economically unfeasible to test the device thoroughly before use. Synonym: humanitarian use device