An investigational device exemption (IDE) is an approval that allows a medical device to be used in a clinical research study that involves human subjects or human specimens. The term “exemption” as it pertains to IDEs, means that the device is exempt from the laws that prohibit unapproved products to move in interstate commerce.
An approved IDE means that the IRB (and FDA for SR devices) has approved the sponsor’s study application and all regulatory requirements are met.
IDEs cover studies that:
- Support marking applications;
- Collect safety and/or efficacy information about a device;
- Evaluate device modifications;
- Collect device specific data about an unapproved device (even if there is no plan to submit a marketing application); or
- Support a new use of a marketed device.