Effects of the Medical Device User Fee and Modernization Act on FDA Review Times for Medical Devices

Eric Sun and Kelly Ferguson
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Kelly Ferguson: Mercury Publication

No 6879, Working Papers from George Mason University, Mercatus Center

Abstract: In the United States, the safety and efficacy of medical devices are regulated by the US Food and Drug Administration (FDA), which must successfully navigate a crucial tradeoff between speed and safety in approving applications for new devices. Although a

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Date: 2016-04-20
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