Safety and Performance Based 510(k)—Mike on Medtech

Safety and Performance Based 510(k)—Mike on Medtech

Mike Drues and Sean Fenske discuss an “abbreviated” 510(k) option for specific, well-understood devices that doesn’t use a predicate.

By Sean Fenske, Editor-in-Chief12.05.19
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Safety and Performance Based 510k pathway, which offers a pathway for medical device manufacturers to use performance criteria in place of a predicate device for clearance. This option, previously known as an Abbreviated 510k, is only available for a select group of well-understood devices that meet FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Specifically, we address a number of questions, including:

  • What is the Safety and Performance 510k?
  • How does it differ from other variations of the 510k, such as the traditional version or the Special 510k?
  • When should a manufacturer consider using this 510k?
  • How does using performance criteria differ from citing a predicate device?
  • Is this simply another way to get “me too” products to market quicker or is there more to it than that?
  • Is this a incentivized way to have companies use more recent products for the comparison without implementing a hardline “10 year” directive?
  • What are the most important takeaways for device manufacturers with regard to this 510k pathway?

If you’d like to review the FDA’s Safety and Performance Based 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 Safety and Performance Based 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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