FDA Guidance on Off-Label Communication, Part 1

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re speaking about off-label communication. More specifically, we’re reviewing a recent guidance from the FDA that offers insights on how off-label communication can be performed in accordance to the regulation. We get a definition of the topic as well as examples of successful off-label communication efforts. During the discussion, the following questions are addressed: Can you first please provide an explanation of what “off-label” is in terms of the FDA? Before getting into the details of this “new” guidance, what is the difference between Off-Label Use vs. Off-Label Communication? What’s new in this “final” guidance? What is meant by firm-initiated communication containing scientific information on unapproved uses? If you communicate with an organization about unapproved (or off-label) uses, what will happen? If you send such a communication, are you acknowledging the off-label use and then need to submit it to FDA for a label expansion? Does FDA need to know about the communication? What else is important? What are the most important takeaways? Listen to this discussion and see if you can benefit from off-label communication. Then check out part 2 of this 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 sfenske@rodmanmedia.com , and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode. Send us Fan Mail For more medtech news and information, visit

You can listen to FDA Guidance on Off-Label Communication, Part 1 online on Radio and Podcast. Open the player on this page to stream the available audio.

FDA Guidance on Off-Label Communication, Part 1 is an episode from Medtech Matters by Medical Product Outsourcing.

This episode is 51:40 long.

This episode was published on May 30, 2025.

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