Glossary Term

Investigational Device Exemption (IDE)

An FDA mechanism that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data.

Under 21 CFR 812, significant-risk device studies require an approved IDE and IRB approval before they can begin. Non-significant-risk device studies follow abbreviated requirements but still need IRB approval and informed consent.

IDE studies must follow GCP-equivalent requirements and report unanticipated adverse device effects promptly.

Need IRB review for your study?

Elemental IRB provides fast, transparent ethical oversight for commercial and academic research.

See pricing → How it works →