What is a Humanitarian Device Exemption (HDE)?
The humanitarian device regulations were first established in October 1994. Humanitarian Use Devices (HUDs) are medical devices specially designated by the FDA for use in the treatment of fewer than 4000 patients per year with rare medical conditions. Intacs corneal implants were approved under a Humanitarian Device Exemption (HDE) by the FDA in July 2004, allowing Intacs to be used for treating keratoconus. Intacs were first designated a Humanitarian Use Device (HUD) by the FDA’s Office of Orphan Products Development in August 2003.
Related Questions
- I believe my combination product may qualify for designation as an orphan drug or biological product, or as a humanitarian use device. Where can I find information about orphan product regulation?
- Can my IVD device be considered a humanitarian use device (HUD) and can I apply for marketing approval through a humanitarian device exemption (HDE)?
- What is a Humanitarian Device Exemption (HDE)?
