Left to their own devices: breakdowns in United States medical device premarket review

Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied.

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Bibliographische Detailangaben
Veröffentlicht in:	PLoS medicine 2010-07, Vol.7 (7), p.e1000280
Hauptverfasser:	Hines, Jonas Zajac, Lurie, Peter, Yu, Eunice, Wolfe, Sidney
Format:	Artikel
Sprache:	eng
Schlagworte:	Corporate sponsorship Device Approval - legislation & jurisprudence Device Approval - standards Drug Approval - legislation & jurisprudence Electroconvulsive therapy Equipment and Supplies - standards Equipment Safety - history Equipment Safety - standards Evidence-Based Healthcare/Methods for Diagnostic and Therapeutic Studies Evidence-Based Healthcare/Quality and Safety in Medical Practice Evidence-Based Healthcare/Statistical Methodologies and Health Informatics FDA approval Federal regulation Food Health care History, 20th Century History, 21st Century Humans Laws, regulations and rules Legislation, Medical Mathematics/Statistics Medical equipment Medical equipment and supplies industry Medical technology Medical test kit industry Non-Clinical Medicine/Health Policy Non-Clinical Medicine/Medical Law Non-Clinical Medicine/Research Methods Pharmaceutical industry Policy Forum Public Health and Epidemiology/Health Policy Safety and security measures Science Policy Testing United States United States Food and Drug Administration
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Beschreibung
Zusammenfassung:	Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied.
ISSN:	1549-1676 1549-1277 1549-1676
DOI:	10.1371/journal.pmed.1000280