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

Forms

HUD application form
HUD continuing report 
HUD consent form (optional, not required)

Regulatory References

21 CFR 814.124 Subpart H
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf