Some common abbreviations used in conjunction with 510(k)
BLA - Biologics License Application (CBER)
CDRH - Center for Devices and Radiological Health
FDA - U.S. Food and Drug Administration
MDUFMA - Medical Device User Fee and Modernization Act
OC - Office of the Commissioner
OCD - Office of the Center Director
OCER - Office of Communications, Education, and Radiation Programs
ODE - Office of Device Evaluation
OIVD - Office of In Vitro Diagnostic Device Evaluation and Safety
OSB - Office of Surveillance and Biometrics
OSEL - Office of Science and Engineering Laboratories
PMA - Premarket approval or application
QSR - Quality System Regulation

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