Investigational Device Exemption

Detailed guidance to assist in preparing and maintaining an Investigational Device Exemption submission.

1. 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).

2. Is My Study Exempt?

Not all clinical device studies need to operate under an IDE. Use the decision tree to determine whether a proposed investigation will require IDE submission and FDA oversight.

3. Is My Study Significant Risk or Nonsignificant Risk?

The IDE regulations (21 CFR part 812) describe three types of device studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies. For studies that are not exempt, sponsors are responsible for making the initial risk determination (SR or NSR) and presenting it to the Institutional Review Board (IRB).

4. Getting Started with an Initial IDE Submission

Preparing an IDE submission can seem daunting. Downloadable templates and detailed descriptions of IDE submission documents and electronic copies can help simplify the task. The 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.

5. FDA Responses

After the IDE submission has been delivered to the FDA, it undergoes a review process and there are several possible outcomes that can occur. This page itemizes potential FDA responses and the steps an investigator should take in each situation.

6. IDE Maintenance

Once the IDE is received and approved, the FDA still must review the investigations at least annually for safety. Additionally, the Prinicipal Investigator is responsible for reporting major protocol deviations (i.e. treating subjects without prior informed consent) and serious adverse events when they occur. Most changes to the investigation including protocol modifications, changes or additions to the clinical site or principal investigator, or changes to the manufacturing process must be sent to the FDA prior to enacting the change.

The type and format of the submission sent to the FDA will depend on the modification. Descriptions and instructions for each situation are listed here.