HDE (Humanitarian Device Exemption)
Beginner
A special U.S. approval for devices that help small groups of people with rare illnesses.
Novice
An FDA approval route for devices that treat rare conditions. The device must be shown to be safe and to offer a probable benefit, but it is exempt from proving effectiveness to the usual standard.
Expert
Approval rests on reasonable assurance of safety and probable benefit, documented in a public Summary of Safety and Probable Benefit.
Explained in Medical devices (Industries).