-
For Industry
-
Designating Humanitarian Use Devices (HUDS)
- Frequently Asked Questions (FAQ): Includes Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
-
Legislation relating to HUDs / HDEs : Includes laws and regulations supporting the mission and scope of the Office of Orphan Products Humanitarian Use Device program.
-
Humanitarian Use Device Resources
-
-
-

