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It’s time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can design your labels around them. Mike Drues, Ph.D. is our guest today giving some great examples of these use statements and successful label designs. He’s the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations. Your intended use and indications of use statements are integral to getting your medical device to market. These statements help insure your device meets regulation when used properly. If you want to bypass any hiccups in your marketing plan, you need to understand the key differences between these two statements: First, intended use is EXACTLY what your product is used for. Don’t focus on what it COULD be used for. Rather, defi