Device Descriptions in Regulatory Submissions

Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing a common part of a regulatory submission—the device description. While this element may seem to be straightforward, an extraordinary number of challenges originate with this portion of a submission. This discussion reviews the role this section plays in a regulatory submission and common mistakes that occur are covered. Specifically, the following questions are addressed:

• Of all the potential topics we could be covering, why has device descriptions come up as one we should discuss?
• What support do you have to say device descriptions are one of the most poorly written sections of a pre-sub or final regulatory submission?
• What is the point of the device description in a regulatory submission? Why would it be so important to get it right?
• How can you verify your device description does its job? How do you know?
• How do you balance technical detail with simplicity in a device description, especially when you’re describing a complex device?
• Is it worthwhile to reiterate the device description in a pre-sub meeting? Shouldn’t the reviewers already be familiar with it if it was included in the pre-sub submission.
• Can you share specific recommendations on how to best write or design a device description?
• Do you have an example you can share?
• What else is important and/or what should listeners take away from this episode?

Listen to this discussion and see if you think you may have submitted device descriptions incorrectly in the past. 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 [e-mail] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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