IDE study
Also written as: IDE — Investigational Device Exemption
A clinical study conducted under FDA authorization to evaluate an investigational medical device for safety and effectiveness.
Full Definition
An Investigational Device Exemption (IDE) study is a clinical investigation conducted under FDA oversight to gather safety and effectiveness data for medical devices not yet approved for commercial distribution. IDE studies are required for most high-risk medical devices, including cardiac devices, before FDA approval. These studies must follow strict protocols for patient consent, data collection, adverse event reporting, and regulatory compliance. IDE studies provide the pivotal clinical evidence needed for premarket approval (PMA) applications.
Usage
Usage note: Always spell out on first use in regulatory documents.
In Context
- "The IDE study enrolled 1,200 patients across 75 investigational sites to evaluate the new lead design." — Regulatory submission
- "IDE study results demonstrated non-inferiority to the predicate device for the primary safety endpoint." — Clinical study report