Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed:Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule?Can you speak to the relationship between intended use and off-label use?When it comes to a medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?Can you share a couple real-world examples of acceptable off-label promotion?Where is the cut-off? In other words, what should com