On Jan. 28, the U.S. Food and Drug Administration (FDA) announced it will strengthen its review process of automated external defibrillators (AEDs) in order to improve the devices’ quality and reliability. The applications for AEDs will be examined a under more rigorous manner to ensure the necessary accessories and the devices themselves are ready to market.

According to the FDA release, “requiring premarket approval for these devices will [allow the FDA to] receive important information about an AED manufacturer’s quality systems information. The FDA will also conduct inspections of manufacturers’ facilities prior to approval. After approval, manufacturers will be required to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance”.

Read the FDA’s announcement.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias

Keywords: Defibrillators, Device Approval, Reproducibility of Results, Safety, United States, United States Food and Drug Administration

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