Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
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1 Introduction
1 Introduction
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of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already on the market, in which case the device does not need to go through the premarket approval process.
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The presentations and panel discussion in Chapter 5 offer a picture of the global regulatory environment of medical devices, including efforts toward global harmonization. Finally, as part of the committee's fact-finding process, participants were offered the opportunity to make 5-minute statements on issues relevant to the committee's task.
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