Investigational Device Exemption Definition

Investigational device exemption (IDE) is a phase in clinical trials for new medical devices. IDE allows sponsors to test their devices for safety and efficacy in multiple patient centers. IDE is granted by the FDA.

Innovations in spine procedures relying on devices, rather than pharmaceuticals, can be tested in patient populations sooner under IDE. Pharmaceuticals must go through longer trial periods before approval is received for testing in human patients.