FDA officials: UDI system a must to improve device surveillance

In a commentary posted this week in the New England Journal of Medicine, Thomas Gross, M.D. and Jay Crowley, M.S.--officials from the Food and Drug Administration--argue that a unique device identification system is necessary to improve the post-market surveillance of medical devices. "We believe that [a new UDI system] will benefit all stakeholders in the healthcare system--patients, clinicians, hospital systems, health insurers, the medical device industry and the FDA--in a number of ways," Gross and Crowley wrote. Chief among those benefits, they say--more accurate and timely reporting of adverse events. Commentary


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