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Mike on Medtech: The Alternative Summary Reporting Program

Mike on Medtech: The Alternative Summary Reporting Program

Sean Fenske and Mike Drues discuss the recently announced cancellation of the alternative summary reporting program and the reasons for it.

By Sean Fenske, Editor-in-Chief05.24.19
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently announced cancellation of the FDA’s alternative summary reporting program, the reasons it existed, why it was cancelled, and what manufacturers will need to do going forward. Specifically, we address a number of questions, including:

  • What is the alternative summary reporting program?
  • Was the reporting of the “discovery” of this program fair or was it media hype?
  • Why did the FDA recently cancel the program?
  • What will medical device manufacturers be required to do now?
  • What is the ultimate result of this ban/change?
  • What are the takeaways and/or lessons to be learned?

Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. 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 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.

Click here to review other episodes of Mike on Medtech.
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