Consumer-'Empowering' Devices Called Out In Gottlieb's First FDA Speech
New US FDA Commissioner Scott Gottlieb made only one direct mention of medical devices in his first speech to the agency, highlighting the promise of devices that empower consumers to be "better stewards of their own care." Gottlieb has been a strong proponent of FDA largely staying out of the oversight of many products in this category, in particular, DTC gene tests and digital-health tools.
You may also be interested in...
Diagnostic testing is increasingly moving from centralized laboratories into pharmacies, physicians' offices, hospitals and directly to consumers as part of the transition to value-based care with its focus on providing quality care at a lower cost. Point-of-care testing (POCT) – and what it means for the future of health-care delivery, health-care providers and creators of innovative technologies joining forces to satisfy consumers' growing appetite for convenient and rapid testing – took centerstage at the recent AACC Annual Meeting in San Diego. This feature takes a closer look at the increasing migration of POCT into the retail arena, specifically pharmacies, to support primary-care providers, along with its challenges. It also highlights emerging trends and technologies, including presentations of the "Star Trek-like" innovations from the Qualcomm Tricorder XPrize competition winners that are bound to disrupt the landscape of direct-to-consumer testing. We also provide expert opinions of the pros and cons of bringing POC services closer to consumers.
Commissioner Scott Gottlieb outlined his plans to implement software provisions of the 21st Century Cures Act and go much further than that in clarifying regulatory policy and piloting novel strategies to streamline the path to market for digital health technologies.
Scott Gottlieb was sworn in as US FDA commissioner May 11. Device-industry lobbyists say championing quick passage of user-fee reauthorization should be his near-term priority. Gottlieb is a well-known figure by some in industry, including AdvaMed chief Scott Whitaker, who served with him at HHS during the George W. Bush Administration.