Humanitarian Device Exemption Updates
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
- Definitions: HUD & HDE
- Prohibition on Profit
- Annual Distribution Number