Understanding the Investigational Device Exemption (IDE) Process

How do you know if your medical device qualifies for an investigational device exemption (IDE)? What does the IDE process involve and what should manufacturers do to meet FDA expectations?

In this episode of the Global Medical Device Podcast, host Jon Speer and his guest David Pudwill “Mr. Regulatory” explore the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and explain to listeners how they can navigate the IDE process in a compliant way.