In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re into part 2 of the discussion (click here to listen to part 1) in an early look at the next Medical Device User Fee Act, MDUFA VI, which would come into use in September 2027. In this portion of the discussion, the lack of details in major deficiency letters is covered. We also take a look at review times and see what the potential impact is to them. During the conversation, the following questions are addressed:

• Can you give a brief summary of the items we discussed in part 1?
• Industry has long complained of a lack of detail in major deficiency letters. What can or should FDA do to address this complaint?
• Does MDUFA VI address FDA review times (i.e., the amount of time FDA has to make a decision) and if so, how?
• Is there anything else in MDUFA VI worth noting?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if you have questions about MDUFA VI. 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.