Investigational Device Exemption

**Semantic type:** Conceptual Entity

**Definition:** Allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a Premarket Notification submission to the Food and Drug Administration.

**Synonyms:** - IDE - Investigational Device Exemption (IDE) - Investigational Device Exemption (IDE) - Investigational Device Exemption (IDE)