Public Citizen Opposes Reclassification of External Cardiac Compressor Devices
September 11, 2013
Public Citizen testified before the FDA’s Circulatory System Devices Panel opposing the reclassification of External Cardiac Compressor (ECC) devices from Class III, requiring premarket approval, to Class I or II, which do not require premarket approval. The best-designed study of these devices, the ASPIRE study, provided strong evidence that death and neurological injury are more common with use of this device compared to manual CPR. Public Citizen recommends that FDA require that these devices be approved through the FDA’s premarket approval process because more testing is needed to show that the devices are safe and effective.