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The Complete Guide to Investigational Device Exemptions

Learn why and when IDEs are required to conduct clinical studies in the United States.

Just about every medical device manufacturer conducting clinical studies will need to determine whether or not an investigational device exemption (IDE) is necessary. We’ve laid out the basics of understanding what an IDE is, to which devices they apply, and how to obtain one.

You’ll learn:

• What an Investigational Device Exemption (IDE) is
• Submission requirements for devices posing a significant risk
• Submission requirements for devices that do not pose a significant risk