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

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  • Sun, Eric
  • Ferguson, Kelly

    (Mercury Publication)

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

Suggested Citation

  • Sun, Eric & Ferguson, Kelly, 2016. "Effects of the Medical Device User Fee and Modernization Act on FDA Review Times for Medical Devices," Working Papers 06879, George Mason University, Mercatus Center.
    • Handle: RePEc:ajw:wpaper:06879
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    File URL: https://mercury.mercatus.org/Product/ViewFinalCopy/221
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    References listed on IDEAS

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    1. Matthew Grennan & Robert J. Town, 2020. "Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices," American Economic Review, American Economic Association, vol. 110(1), pages 120-161, January.
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