The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?

J Neurointerv Surg. 2013 Jul;5(4):269-75. doi: 10.1136/neurintsurg-2012-010400. Epub 2012 Jul 4.

Authors

Kyle M Fargen¹, Donald Frei, David Fiorella, Cameron G McDougall, Philip M Myers, Joshua A Hirsch, J Mocco

Affiliation

¹ Department of Neurosurgery, University of Florida, Gainesville, Florida, USA. kyle.fargen@neurosurgery.ufl.edu

PMID: 22764203
DOI: 10.1136/neurintsurg-2012-010400

No abstract available

Keywords: Aneurysm; artery; spine; standards; subarachnoid; thrombectomy; vein.

Publication types

Review

MeSH terms

Device Approval / legislation & jurisprudence
Device Approval / standards*
Equipment and Supplies / standards*
Humans
Inventions / legislation & jurisprudence
Inventions / standards*
Inventions / trends
United States
United States Food and Drug Administration / legislation & jurisprudence
United States Food and Drug Administration / standards*
United States Food and Drug Administration / trends