In this post, we outline what University of Minnesota sponsor-investigators need to submit in their initial Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA).
When to submit an IDE application
The FDA requires an IDE application when an investigator is studying either:
- Unapproved medical devices.
- An approved device for a new indication or in a new patient population
A study in either of these categories may not proceed without permission from the FDA. In the United States, the use of a device in one or more persons other than use of an approved device in the course of medical practice may require an IDE.
IDE applications are reviewed by the FDA’s Centers for Device and Radiological Health (CDRH), unless the intervention includes a novel biologics component, in which case the application is reviewed by the Center for Biologics Evaluation and Research (CBER).
Note that an IDE submission is different from a Premarket Approval (PMA), which is submitted to the FDA after clinical trials are completed and when the device is ready for approval and marketing.
An IDE application should be initiated prior to IRB submission to ensure an IDE number has been assigned to the project.
Checklist: What’s required for an IDE application
UMN Central File Submission
All FDA communications, including submissions and receipts, must be submitted to the University’s Central File per UMN policy.
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