FDA Panel Recommends Strict Regulation of External Defibrillators

Tuesday, January 25, 2011

NSPE Senior Manager of Government Relations Sarah Ogden attended a meeting of the Food and Drug Administration's Circulatory System Devices Panel. The panel is charged with reviewing and evaluating data concerning the safety and effectiveness of marketed and investigational devices used in the circulatory and vascular systems and making recommendations to the Commissioner of Food and Drugs.

As part of FDA's External Defibrillator Improvement Initiative, the panel was reviewing the regulatory classification of automated external defibrillators. After hearing from manufacturers and FDA, the panel recommended continuing to classify AEDs as Class III devices, which subjects AEDs to the stringent premarket approval process.