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More Information on the Device Review Process

Public Citizen comments on regulatory classification of automated external defibrillator (AED) devices

June 24, 2013

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Public Citizen supports the Food and Drug Administration’s (FDA’s) proposed order requiring premarket approval applications for automated external defibrillator (AED) devices. Public Citizen’s Health Research Group previously offered testimony before the FDA Panel on Circulatory System Devices of the Medical Devices Advisory Committee on January 25, 2011, urging the panel to recommend that AED devices remain in Class III and be reviewed through the premarket approval (PMA) process, a recommendation that the panel ultimately adopted.

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