Beyond 510(k)/PMA: De Novo 101—Mike on Medtech

Beyond 510(k)/PMA: De Novo 101—Mike on Medtech

Sean Fenske and Mike Drues discuss the third most common regulatory pathway—the De Novo—clearing up details about its advantages and when it's used.

By Sean Fenske, Editor-in-Chief07.02.19
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the third most commonly used (although still substantially less than the 510(k) and PMA) regulatory pathway available to medical device manufacturers. Since it is not nearly as common as the two primarily used pathways, the De Novo is not nearly as understood as them. In order to shed light on when this option could be most beneficial or be the best option for a regulatory submission, we attempt to provide an overview of it—a De Novo 101, if you will. Specifically, we address a number of questions, including:

  • What is the De Novo regulatory pathway?
  • How does the De Novo differ from the PMA and 510(k) regulatory pathways?
  • For what situation or type of device is the best case to use the De Novo pathway?
  • When shouldn’t the De Novo be used?
  • Do you have any suggestions or best practices for using a pre-sub meeting when planning to use the De Novo pathway?

Listen to this episode and see what you think of this regulatory pathway. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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