• 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