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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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Detalhes bibliográficos
Publicado no:JACC Basic Transl Sci
Autor principal: Van Norman, Gail A.
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier 2018
Assuntos:
Acesso em linha: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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