Modernizing Device Regulation

At what point does a modification of a device warrant an entirely new approval process? And who should make that decision? Dr. Alan Garber describes how the FDA might best approach its role as a device regulator. The Food and Drug Administration (FDA) is known for its rigor in regulating drugs, not...

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Veröffentlicht in:	The New England journal of medicine 2010-04, Vol.362 (13), p.1161-1163
1. Verfasser:	Garber, Alan M
Format:	Artikel
Sprache:	eng
Schlagworte:	Clinical Trials as Topic - legislation & jurisprudence Defibrillators, Implantable - adverse effects Device Approval - legislation & jurisprudence Equipment and Supplies - adverse effects Equipment and Supplies - classification Equipment Failure FDA approval Federal regulation Government Regulation Humans Jurisprudence Medical equipment Regulation of financial institutions United States United States Food and Drug Administration
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