MDA Medical Device Amendments of 1976
MDR medical device reporting
NDA new drug application
NSE not substantially equivalent
PMA premarket approval
QSR quality systems regulation
TPLC total product life cycle
The National Academies of Sciences, Engineering, and Medicine
500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report.
Washington, DC: The National Academies Press, 2010.
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