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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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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Elsevier
2018
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6115642/ https://www.ncbi.nlm.nih.gov/pubmed/30175277 http://dx.doi.org/10.1016/j.jacbts.2018.06.006 |