Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.
Mark Goodman and Barry Thompson, Baker & McKenzie LLP03.04.20
The agency believes that additional changes are needed to fully modernize the 510(k) program.
Scott Gottlieb, M.D. & Jeff Shuren, M.D.;, Commissioner & Director of the Center for Devices and Radiological Health; U.S. Food and Drug Administration04.30.19