Humanitarian Device Exemption

**Semantic type:** Intellectual Product

**Definition:** A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA.

**Synonyms:** - HDE - HUMANITARIAN DEVICE EXEMPTION - Humanitarian Device Exemption (HDE)