On-Demand Webinar

Device Descriptions: The Most Poorly 
Written Part of Medical Device Submissions

In medical device pre-submissions as well as final submissions to FDA, the device description is one of the most poorly written sections of the submission. Why? Because the vast majority of questions from reviewers demonstrates that the reviewer does not understand the device, i.e., what it does, how it works, it's mechanism of action (MOA), etc. This is direct evidence that the device description is the root cause of many of these misunderstandings!  In spite of this, or perhaps because of this, there is very little “guidance” regarding preparing effective device descriptions.

Simply put: it’s incumbent on the medical device manufacturer to make sure the that FDA understands the device and NOT the other way around!  In other words, if FDA does not understand your device, there is little point of discussing your regulatory strategy, testing matrix, clinical data plan or anything else!

This webinar will use the case study approach to present the device description process in an interactive fashion including:

• How do I prepare an effective device description?  What should go into it and what should not?
• What level of detail should I include in my device description?
• Why is it critical to get the device description right?  What are the consequences if I don’t?
• What is the relationship between my labeling and my device description?
• Should I use my competitor’s device description as a template for mine?
• How does my device description impact my regulatory strategy?
• Must I use only words to describe my device?
• Is it worthwhile to reiterate your device description in a pre-sub meeting?
• How do I know if my device description is adequate? What should I do if it’s not?

In this webinar, participants will learn best practices to avoid timely and costly mistakes and creative ways to use device descriptions to their advantage!  Device descriptions are required for all medical device submissions, yet most of them are very poorly written and are a common source of questions, misunderstandings, unnecessary testing and delays.