Whether wearables and other digital health products are subject to regulation by the U.S. Food and Drug Administration (FDA) is largely a question of how these products are intended to be used. Although FDA has indicated that low-risk, consumer wearables, such as Fitbits, will not be the focus of regulatory oversight, higher-risk, “medical grade” products will likely be subject to FDA scrutiny. This session will review the regulatory landscape surrounding wearables, implantables, and digital health devices.