What is an IDE?
An IDE is a regulatory submission that permits clinical investigation of devices to determine safety and effectiveness. An FDA-approved Investigational Device Exemption Application (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device (21 CFR 812.1).
IDE Exemption Criteria and Study Risk Determination
Not all clinical studies need to operate under an IDE. Use the decision tree to determine whether a proposed investigation will require IDE submission and FDA oversight.
Initial IDE Submission
An initial IDE submission to the FDA will provide the reviewers with the information necessary to conduct a thorough evaluation of the safety of the investigation, and its scientific merit. The submission is divided into several sections. The summaries listed in this page will provide detailed instructions to prepare a complete IDE submission.
FDA Responses and Meetings
After the IDE submission has been delivered to the FDA, it undergoes a review process with several possible outcomes. This page itemizes potential FDA responses and the steps to take in each situation.
IDE Maintenance
Once the IDE is received and approved, the FDA must review the investigations at least annually for safety. Additionally, there are requirements for reporting major protocol deviations and serious adverse events when they occur. Most changes to the investigation, including the protocol, the clinical site or principal investigator, or the manufacturing process, must be sent to the FDA prior to enacting the change.