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Mike on Medtech: MDUFA IV and Its Impact on Medtech Innovation

Mike on Medtech: MDUFA IV and Its Impact on Medtech Innovation

Mike Drues and Sean Fenske discuss the harmful effect the latest version of MDUFA could have on medtech development.

By Sean Fenske, Editor09.07.17
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the passage of MDUFA IV and the changes that are associated with it. Further, we discuss the potential impact this law will have on medical device innovation. In an era of politicians calling for greater healthcare technology and a reduction of healthcare costs, stagnating innovation in medtech seems to be counterintuitive to this demand; unfortunately, that’s exactly what MDUFA IV could do. This law could adversely impact the design and development of medical devices based on companies seeking to avoid the increased fees. Examples of companies changing their product submission strategy are also shared. Specifically, the following questions are addressed:

  • This is the fourth version of MDUFA, which has been around for quite some time now. Why is this latest version significant?
  • What are the significant changes in this version of MDUFA ?
  • What about those companies who are currently in the submission process? What should they do?

Get more information regarding the MDUFA IV legislation via the following links:
Overview: Medical Device User Fee Amendments (MDUFA)
Specific Fee Schedule: FY 2018 MDUFA User Fees

Listen to the podcast streaming via the player below or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.



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 MDUFA IV and its potential impact on medtech innovation, 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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