Investigational Device Exemption (IDE) Investigational Device Exemption (IDE)
An approval given by the United States Food and Drug Administration to use a medical tool, instrument, test, or method in a study that enrolls people.
Example of Investigational Device Exemption (IDE) in a sentence
Researchers submit an Investigational Device Exemption application to the FDA to get permission to study a device’s safety and find out how well it works in people.
More Info
The Investigational Device Exemption (IDE) application is specific to the United States (US).
Researchers submit an IDE application to the US Food and Drug Administration (FDA) for approval to study its effectiveness and safety. After approval, the research is said to be done “”under an IDE.”
Some, but not all, investigational devices need an IDE before they can be studied in people. High-risk devices require an IDE before they can be used in a study.
Other info to think about when joining a study
You may see or hear the term “investigational device exemption” if you are thinking about joining a study that is using a medical object or medical test that has not yet been approved by the US FDA.
If you join a study that is testing a device under an IDE, you can learn more about the device and ask what safety information the study team already has. Because there is an IDE, these devices could be riskier, so you can always ask what potential risks the study team already knows about and how they plan to keep participants safe.
If an investigational device is put into your body, you may want to learn more about what will happen to it when the study is over.
You can also ask about what kind of care you will have access to if any harm or injury occurs that was possibly caused by the investigational device.
