In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking an early look at the next version of the Medical Device User Fee Act, MDUFA VI, which would go into effect in September 2027. The conversation involves changes to the pre-sub (or Q-sub) meeting with the agency as well as the possible addition of a fee associated with it. There’s also talk around potential changes for the de novo pathway. During this conversation, the following questions are addressed:

• What is the Medical Device User Fee Act (a.k.a., MUDFA) and why do we have it?
• Is there a downside to MUDFA?
• Medical device user fees have been around since 2003. So, what is new or noteworthy in the 2027 version?
• One update to the program would be to create a “focused follow-up pre-submission process” by the end of 2027, allowing sponsors to receive responses faster than with a traditional pre-submission request. Any comments on that?
• We have previously discussed in depth the de novo pathway to market, how it compares to the 510k, and the reasons why the de novo’s popularity has increased significantly over the past decade. Does MDUFA VI include any changes to the de novo?

Listen to this discussion and then check out part 2 to hear the rest of the discussion. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected], and we’ll see if your ideas/inquiries/suggestions align with a future 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.