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Expanded Patient Access to Investigational New Devices: Review of Emergency and Nonemergency Expanded Use, Custom, and 3D-Printed Devices

U.S. Food and Drug Administration (FDA) approval of Class III medical devices can take from 3 to 7 years. Although this is shorter than times for drug approvals, patients with serious or life-threatening diseases and disorders may not have time to wait for device approval to access needed treatments...

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書目詳細資料
發表在:JACC Basic Transl Sci
主要作者: Van Norman, Gail A.
格式: Artigo
語言:Inglês
出版: Elsevier 2018
主題:
在線閱讀:https://ncbi.nlm.nih.gov/pmc/articles/PMC6115642/
https://ncbi.nlm.nih.gov/pubmed/30175277
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.jacbts.2018.06.006
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