Glossary of Terms

Humanitarian Use Device (HUD)

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Compliance & Regulatory: MedTech

An HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States per year. The Office of Orphan Products Development (OOPD) determines if a device meets specific requirements, including scientific rationale and population prevalence, for designation as a HUD.