The Special 510(k) Program—Mike on Medtech

The Special 510(k) Program—Mike on Medtech

Mike Drues and Sean Fenske discuss a 510(k) option for modifications to a company's legally marketed medical device.

By Sean Fenske, Editor-in-Chief11.13.19
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, we address a number of questions, including:

  • What is the Special 510(k) program and how does it differ from the standard 510(k) program?
  • When is it appropriate for a device manufacturer to use this program?
  • In January 2018, we discussed the then new alternative 510(k) (click here to listen to that podcast). How is this different from that?
  • Is this yet another specialized version of the 510(k) to better address the industry needs? Are we creating too many “special case” 510(k) variations or is this ultimately a good thing?
  • What are the most important takeaways of this guidance listeners should keep in mind?

If you’d like to review the FDA’s Special 510(k) program guidance document (finalized September 2019) before listening to this podcast, you can find it by clicking here.

Listen to this episode and see what you think of the Special 510(k). 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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