Virtually every device manufacturer that studies humans needs to determine whether an investigational device exemption is necessary.

With that in mind, device manufacturers should understand what an investigational device exemption is, to which devices it applies, and how to obtain an investigational device exemption if it is needed.

Let's start with the basics:

What is an Investigational Device Exemption?

An investigational device exemption allows an unapproved device to be used in clinical studies to collect data regarding its safety and efficacy.

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