Closing an IDE

The procedures for closing an IDE vary depending upon at what point in the process the decision to close the IDE occurs.

• If FDA has not yet approved the IDE, the sponsor may simply request to withdraw their IDE from FDA review.
• If the sponsor submits such a request, FDA will acknowledge the request by issuing boilerplate G-39 and the IDE will then be considered closed.
• After this point, if the sponsor decides to pursue an investigation of the device, a new IDE would need to be submitted; however, the closed IDE may be referenced in the new application
• If FDA has approved the IDE but no subjects have been enrolled, the sponsor may still request withdrawal of their IDE. In this case, however, the sponsor should state that no subjects had been enrolled and account for all devices (i.e., state that no devices were shipped or that all shipped devices have been returned, destroyed or otherwise disabled).

Once subjects have been enrolled in the study, the sponsor should not terminate the IDE until all enrolled subjects have completed follow-up in accordance with the approved investigational plan.

The sponsor may cease enrollment in the study, but complete follow-up should be obtained for all subjects already entered into the study. Boilerplate G-35 may be used to acknowledge termination of subject enrollment. This letter reminds the sponsor of the need to follow all subjects in accordance with the investigational plan.

When follow-up is complete for all enrolled subjects, the sponsor should submit a final report to FDA and all reviewing IRBs within six months. The ODE Guidance entitled "Suggested Format for IDE Final Report" outlines the information that should be included in a final report.

Boilerplate G-33 acknowledges termination of the study and submission of the final report and closes the IDE. Boilerplate G-34 is used when the final report is inadequate and additional information is requested. The IDE is not officially closed until the final report is complete. It should be noted that the sponsor may reference a PMA or 510(k) application to fulfill the IDE requirement for submitting a final report. If the PMA or 510(k) application contains a summary of the progress of the device investigation, the sponsor may submit a letter to FDA stating that a marketing application has been submitted and where the progress report can be located in the marketing application (i.e., PMA or 510(k) number, date of submission, volume and pages).