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  1. Designating Humanitarian Use Device (HUD)

Education and Media Resources for HUD Program

The resources below are educational recordings about Humanitarian Use Device and the FDA. The table below identifies the intended audience for each of the topics; however, these educational resources are meant to serve as a beneficial tool to all rare disease stakeholders.

Please note that these materials have not been updated to reflect that on December 13, 2016, the 21st Century Cures Act (Pub.L. No. 114-255) changed the population estimate required to qualify for Humanitarian Use Device (HUD) designation from "fewer that 4,000" to "not more than 8,000."

Recorded Session Topic

Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE)

Module 1: Office of Orphan Products Development
Presentation   Printable Slides   Transcript

Module 2: Humanitarian Use Device (HUD): Program Overview
Presentation   Printable Slides   Transcript

Module 3: Humanitarian Device Exemption (HDE): Program Overview and Pre-approval Activities
Presentation   Printable Slides   Transcript

Module 4: Humanitarian Device Exemption (HDE): Post-approval Activities
Presentation   Printable Slides   Transcript