General Versus Specific Uses For a 510(k)

Published on January 29, 2016
Categorized as Submissions

Follow the yellow brick road

Our client, a medical device company, had a cleared 510(k) device with general intended use statement for use as a “tool” not a “treatment.”  They needed to find a way to describe to physicians the patients for whom the device could be used in promotional materials, their website and medical convention booth panels and in sales training.  Management wanted to properly promote the device without getting into trouble with FDA and getting a Warning Letter. 

We took the management team through an analysis of FDA’s General/Specific Use Guidance as well as FDA’s Guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], July 28, 2014” to determine what is considered an on-and off-label use of their device.   We then created a promotional messaging matrix to help their marketing, sales and clinical organization to know what they could and could not say about how and in whom the product can be used.  We then help them understand the three “buckets” of promotion, off-label dissemination and communication to help establish a new comprehensive marketing strategy.


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