As suppliers can impact product quality, device manufacturers must oversee them as though they were an extension of the company and not an outside entity.
Seth Goldenberg, Ph.D., and Carl Ning, Veeva Systems03.04.20
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
FDA has determined the manufacturers, Boston Scientific and Coloplast, haven't demonstrated reasonable assurance of safety and effectiveness for these devices.
t:Slim X2 is the first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices.