Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidance on Multiple Function Device Products. While the terminology can be somewhat confusing, the guidance, and more importantly, how manufacturers comply with it is relatively straightforward. Specifically, we address a number of questions, including:What is a multiple function device as it relates to the FDA’s guidance?What’s the difference between a regulated medical device and a consumer product?How does something like a multiple function device differ from a combination product?What regulatory strategy suggestions do you have for dealing with this type of device?What concerns exist from a regulatory viewpoint if a sensor, such as a camera, is updated for non-regulated purposes? Will that impact the clearance of a regulated product that leverages that camera for sensing, such as a visual detection app that can detect skin cancer?What other significant takeaways from this guida