If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. But if you’re becoming more involved with the world of digital health, as many pharma companies are these days, you may find that your old FDA knowledge isn’t much help in knowing what will be required of you. A lot of innovators are in the same boat as, despite laudable efforts by the agency, there’s still a lot of misinformation and a lack of clarity around how digital health devices, especially software as a medical device, are regulated. At the American Telemedicine Association conference last month, I sat down with Kyle Faget, a partner at Foley & Lardner who comes from a pharma background but now advises clients about digital health device regulation. Here’s some key takeaways from our conversation.
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