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Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices

As with new drugs, the U.S. Food and Drug Administration’s approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use. Bringing a device to market takes an average of 3 to 7 years, compared with...

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Detalhes bibliográficos
Publicado no:JACC Basic Transl Sci
Autor principal: Van Norman, Gail A.
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6113340/
https://ncbi.nlm.nih.gov/pubmed/30167516
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.jacbts.2016.03.009
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