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Mike on Medtech: 510(k) Modernization

Mike on Medtech: 510(k) Modernization

Sean Fenske and Mike Drues discuss the potential changes coming to the 510(k) regulatory pathway and examine the issues around predicate devices.

By Sean Fenske, Editor-in-Chief01.25.19
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s announcement of their effort to modernize the 510(k) regulatory pathway. This podcast is an extension of the MPO January/February Editor’s Letter on the same topic. (Click here to read that Editor's Letter.) Specifically, we address a number of questions, including:

  • Late last year, the FDA announced their efforts to modernize the 510(k) clearance pathway. Predicate devices seems to be a focal point. Is there a reason for the agency to seek to cut off the predicate device at 10 years or is that really just an arbitrary number they selected?
  • If we were to cut off predicate devices at a certain time from being used, are we doing a disservice to all stakeholders involved? Do older predicate devices still offer advantages to the regulatory approval process?
  • Is this a reactionary move to the bad press the FDA (and industry as a whole) suffered last year, such as the release of the findings from the International Consortium of Investigative Journalists and The Bleeding Edge documentary or was this already in the works?
  • Is the current version of the 510(k) pathway worth saving or is it long since outdated from when it was first launched?
  • In my Editor’s Letter, I reference an article that’s also running in the same issue, which focuses on value-based healthcare. In that article, the author, Vicki Anastasi of ICON, explains that a PMA pathway for device approval could be a better option for a company from a financial or reimbursement standpoint. Do you agree?

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 at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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