Investigational Device Exemption (IDE)

So you think you need an IDE?

Clinical studies are usually expensive undertakings and can have significant regulatory hurdles to overcome. Many clinical studies require a FDA approved IDE before they can begin. A link to the
FDA regulations for IDEs can be found here and FDA has plenty of guidance here and especially here. But before you start totaling up costs or digging into the regulations, there are two basic questions to consider and two more things to think about.