1.
J Vasc Interv Radiol
; 26(9): 1324-30, 2015 Sep.
Artigo
em Inglês
| MEDLINE
| ID: mdl-26189046
RESUMO
The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.
Assuntos
Pesquisa Biomédica/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Regulamentação Governamental , Radiologia Intervencionista/instrumentação , Radiologia Intervencionista/legislação & jurisprudência , United States Food and Drug Administration/organização & administração , Estados Unidos
2.
Med Health R I
; 95(5): 149, 152, 2012 May.
Artigo
em Inglês
| MEDLINE
| ID: mdl-22808633