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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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Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:JACC Basic Transl Sci
Prif Awdur: Van Norman, Gail A.
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: Elsevier 2016
Pynciau:
Mynediad Ar-lein: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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