Foley & Lardner LLP Partner Kyle Faget is featured in the Q&A, “Four things you need to know about FDA regulations and digital health,” with pharmaphorum discussing the lack of clarity around how digital health devices, especially software as a medical device, are regulated.
Faget's background is in pharmaceuticals, but now she advises clients about digital health device regulation. In the conversation, she discusses how U.S. Food and Drug Administration (FDA) digital health regulations can be complex and difficult to understand. Her key takeaways include:
“A device means a product that’s used in the diagnosis of disease and intended to affect the structure and function of the body of humans... And – this is a really important thing – does not achieve its primary intended purposes through chemical action within or on the body and is not dependent on being metabolised for the achievement of its primary intended purpose. So that really is what distinguishes a medical device from, for example, a drug or biologic."
“The breadth of medical devices in terms of safety, it’s enormous. You have a pacemaker on one end and a tongue depressor on the other, and then FDA has to figure out a regulatory scheme that takes into account every one of them, again, without stifling innovation.”
“Device manufacturers, especially software developers, are used to constant iteration, which doesn’t necessarily play well with a traditional regulatory process. FDA has sought to address this in different ways, including a new Pre-Certification Process that will eventually allow companies to fast-track products under certain circumstances.”
“There’s a whole ton of questions about, well, am I subject to regulation or not?” Although clarification from the FDA can be slow, “If you move too quickly and have a regulatory misstep, the penalties there can be relatively large. You can end up with a warning letter from FDA that sits out there publicly forever.”