Humanitarian Use Device (HUD) 

• Medical Device intended to benefit patients in treatment or diagnosis of disease/condition in not more than 8,000 individuals in US/year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255).

Humanitarian Device Exemption (HDE)

• Marketing Application for an HUD;  exempt from the effectiveness requirements and is subject to certain profit and use restriction

Learn about

• Definitions: HUD & HDE
• Prohibition on Profit
• Annual Distribution Number

LEARN