Federal Register Proposed order: FDA is proposing to require the filing of a PMA or a notice of completion of a product development protocol for the following Class 3 preamendments devices: automated external defibrillator systems (AEDs), which includes the AED device and its accessories (i.e., pad electrodes, batteries, and adapters). The agency is also summarizing its proposed findings on 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. To view this proposed order, click here.