The FDA has proposed that filing of a premarket approval application (PMA) or a notice of completion of a product development protocol be required for automated external defibrillators systems (AEDs) and their accessories.
The agency announced that it also is summarizing 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, the FDA will provide an opportunity for people to request that the agency change the classification of the AED based on new information. This action implements certain statutory requirements.
AEDs are class III preamendments devices, which are devices that were in commercial distribution before the enactment of the Medical Device Amendments of 1976. A preamendments class III device may be commercially distributed without a PMA until 90 days after the FDA issues a final order requiring premarket approval for the device, or 30 months after final classification of the device.
The FDA now is proposing to require that a PMA be filed. An applicant whose device was legally in commercial distribution before May 28, 1976, or whose device has been found to be substantially equivalent to such a device, will be permitted to continue marketing devices during FDA's review of the PMA, provided timely filing of the PMA. The FDA said it intends to review PMAs within 180 days.
The FDA will accept electronic or written comments until June 24. Identify comments as Docket No. FDA-2013-N-0234.