Gaining an Advantage Through Class II Special Controls—Mike on Medtech

Gaining an Advantage Through Class II Special Controls—Mike on Medtech

Mike Drues and Sean Fenske look at the FDA’s Special Controls that are tied to Class II medical devices and how they can be leveraged by a company.

By Sean Fenske, Editor-in-Chief10.25.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA’s regulatory requirements for Class II devices. During the conversation, the purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to gain a competitive advantage is also discussed. Specifically, the following questions are addressed:

  • Would you please explain what we mean by Special Controls? What are they, and how and when are they used?
  • What makes these “special”?
  • Would you mind providing some real-world examples of Special Controls?
  • How do Special Controls vary based on the regulatory pathway? In other words, how are they different from 510k vs a de novo?
  • With regard to Special Controls, what are the most important takeaways to keep in mind?

Listen to this episode and see if you can leverage Special Controls to gain a competitive advantage. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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