What Does 510k Exempt Actually Mean?—Mike on Medtech

What Does 510k Exempt Actually Mean?—Mike on Medtech

Mike Drues and Sean Fenske review the term and discuss what types of devices are exempt, as well as the meaning of the term itself.

By Sean Fenske, Editor-in-Chief11.29.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:

  • Could you please explain what 510k exempt actually means?
  • Are all Class I medical devices exempt and all Class II devices not exempt?
  • What’s the difference between Class I exempt and Class II exempt?
  • What is the difference between general controls and special controls? How are these relevant to exempt status?
  • Could you give some examples of products that are Class I exempt and explain why they are afforded that status?
  • Now could you do the same for Class II products that are exempt and give reasons why?
  • What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see how 510k exempt may affect your company’s products and future regulatory submissions. 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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