FDA Regulations and Digital Health Discussed by Kyle Faget


Drugs and devices are two completely different animals

Medical devices have a lower floor in terms of risk

Development processes for devices are different, and FDA knows it

“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.”

Story Highlights

  • 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.”

“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.”

FDA’s digital health regulation can be hard to parse, even for experts

“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.”