A Letter to File Deep Dive—Mike on Medtech

A Letter to File Deep Dive—Mike on Medtech

Mike Drues and Sean Fenske discuss how a letter to file is to be used, when to use it, and how to avoid problems with FDA.

By Sean Fenske, Editor-in-Chief10.04.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it’s appropriate to use this pathway? Also, how do you ensure you are using a letter to file correctly so as to avoid challenges that could arise with the FDA? Specifically, the following questions are addressed:

  • While we’ve mentioned letter to file a number of times in other podcasts, can you please take a minute to explain exactly what a letter to file is and when it should be used?
  • Why is a letter to file important?
  • When does a medical device company submit a letter to file to the FDA?
  • Does the FDA provide any guidance on a letter to file or offer a template to use for it?
  • What goes into a Letter to file?
  • Can you provide some real-world examples of when to consider using a letter to file versus not using one? Does the type of change matter?
  • Are there situations where using a letter to file could result in an adverse effect to what was intended?
  • When it comes to a letter to file, what are the most important takeaways for listeners to keep in mind?
Listen to this episode and see if you better understand the point of the letter to file and when to use it. 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 sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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