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Mike on Medtech: Benefit-Risk Determinations

Mike on Medtech: Benefit-Risk Determinations

Sean Fenske and Mike Drues discuss two FDA guidance documents that focus on considerations and uncertainty in making benefit-risk determinations.

By Sean Fenske, Editor-in-Chief09.16.19
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two recently issued FDA guidance documents. As they can be coupled together, we discussed both in one podcast. They are:
  • Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (August, 2019) (Click here to read the guidance.)
  • Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August, 2019) (Click here to read the guidance.)

Specifically, we address a number of questions, including:
  • Can you please provide a brief overview of what's in these guidances and what their purpose is?
  • Why is PMA, HDE and de novo included but 510k is NOT included in this guidance?
  • When is higher risk acceptable and what is the tie-in to the term uncertainty?
  • What else is important in these guidances and what are the most important takeaways for listeners?

Listen to this episode and see what you think of these two benefit risk determination guidances. 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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