On January 28, 2015, the FDA issued a final order which represents a custom approach to help manufacturers assure the quality and reliability of AEDs. The FDA is now requiring manufacturers to obtain premarket approval (PMA) for all future as well as currently marketed AEDs and their accessories.
Automated External Defibrillators automatically analyze the heart rhythm in people of cardiac arrest and provide an electrical shock to the heart to restore its normal rhythm. Although they can save lives, AEDs have had some manufacturing problems and many have been recalled, which has led to this decision.
Keeping the importance of AEDs in mind, the devices that are currently on the market will still remain available while manufacturers work to meet the new PMA requirements of the FDA.
Visit the FDA's official site to learn more about this and other Defective Drugs and Medical Devices.