The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators systems (AEDs), which includes the AED device and its accessories (i.e., pad electrodes, batteries, and adapters). A review of Medcial Devie Reporting (MDR) database indicated that the total number of MDRs submitted annually more than doubled from 2005 to 2010. A review of reports submitted from 2011 and 2012 shows that the number of submitted adverse events reports has continued to increase.The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute’s premarket approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the automated external defibrillator based on new information. This action implements certain statutory requirements. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market the device will need to submit a PMA within 90 days of the publication date of the final order. Please see section III for more information about submitting a PMA. Please also see section IX for the proposed effective date of any final order that may publish based on this proposal. CLICK HERE for the posting.