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Mike on Medtech: A Pre-Sub for 483s, Part 1

Mike on Medtech: A Pre-Sub for 483s, Part 1

Sean Fenske and Mike Drues discuss a recently released FDA guidance that outlines a specific communication protocol to address certain 483s with the agency.

By Sean Fenske, Editor-in-Chief05.09.19
In the first part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around what this guidance is, what’s new about it, and whether or not it’s actually something we need. Specifically, we address a number of questions, including:

  • What’s lead to this new guidance? Do we really need it?
  • Why is FDA doing more inspections?
  • What is the goal of this guidance/program?
  • What is the difference between Form 483 and Warning Letter?
  • What is the process described in this guidance?
  • What does FDA respond with?

Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. 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 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.

Click here to review other episodes of Mike on Medtech.
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