Open AccessModernizing Device Regulation
Author(s) -
Alan M. Garber
Publication year - 2010
Publication title -
new england journal of medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 19.889
H-Index - 1030
eISSN - 1533-4406
pISSN - 0028-4793
DOI - 10.1056/nejmp1000447
Subject(s) - medicine , food and drug administration , drug , risk analysis (engineering) , drug approval , pharmacology , intensive care medicine
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.
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