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1 Pre-Market Approval
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2 Food and Drug Administration
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3 A 510(k) is a term commonly used to refer to a pre-market application sent to the FDA. The information in this application documents the safety and efficacy of the finished medical device. If the FDA deems the device to be substantially equivalent to an adequate legally marketed medical device that is currently approved for marketing in the United States, clearance is granted to market the product. Visit www.fda.gov/cdrh/510khome.html for more information.
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Bérubé, D. (2008). Entrepreneurship in Medical Device Technologies. In: Madhavan, G., Oakley, B., Kun, L. (eds) Career Development in Bioengineering and Biotechnology. Series in Biomedical Engineering. Springer, New York, NY. https://doi.org/10.1007/978-0-387-76495-5_13
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DOI: https://doi.org/10.1007/978-0-387-76495-5_13
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