Humanitarian Use Device (HUD)
A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in less than 4,000 individuals in the United States per year.
Before a HUD can be used at a facility operating under the jurisdiction of the WFH-IRB, the HUD must be reviewed and approved by the full IRB.
HUD definitions, procedures and reporting
HUD application form
HUD continuing report
HUD consent form
(optional, not required)