Resources
- Listing of CDRH Humanitarian Device Exemptions Database
- Humanitarian Device Exemption (HDE) Database
- Developing Products for Rare Diseases & Conditions
- Designating Humanitarian Use Device (HUD)
- Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff
- Webinar - Humanitarian Device Exemption Program - October 21, 2019
- Humanitarian Use Device (HUD) Designations
- CDRH Learn HDE Modules (section on “How to Study and Market Your Device”)
- eCopy Program for Medical Device Submissions
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program