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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report (2010)
Board on Population Health and Public Health Practice (BPH)

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. "Front Matter." 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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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report

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

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