FDA's Intended Use Rule’s Relation to Labeling

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed:

• Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling?
• How can labeling, both high level and low level, be used as a strategic advantage?
• Could you please explain the difference between intended use and indications for use?
• What is this intended use rule and why is it important to medical device manufacturers?
• What is meant by manufacturer's objective intent?
• Do you have examples you can provide?
• What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see how Intended Use affects your device labeling. 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 we want to address your ideas/inquiries/suggestions in a future episode.

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