The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). More...
Public Comments in Response to Proposed Order
In response to the March 25, 2013 (78 FR 17890) proposed order to maintain the class III classification and require premarket approval for AED systems, FDA received 66 comments and one petition for reclassification. (See Sudden Cardiac Arrest Foundation comments here.)
According to the Federal Register, many comments indicated that AED systems have already been demonstrated to be safe and effective, and referenced literature and studies supporting the reliability of these devices and the value of AED systems in treating sudden cardiac arrest (SCA). The comments stated that PMAs and associated increased regulatory cost and review time is not warranted and would hinder innovation, increase device cost to consumers, and reduce availability of AED systems. The comments further stated that it is widely recognized that improvement in the survival rate from SCA is due in large part to widespread distribution of AED systems and expressed concern that requiring PMAs would limit availability of the devices.
In response, the FDA stated it agrees that many currently marketed AEDs have been demonstrated to be effective in clinical use and, when designed and manufactured appropriately, AEDs can be safe and effective. However, FDA believes that there is insufficient information to determine that general and special controls would provide a reasonable assurance of the safety and effectiveness of these devices, which are for a use in supporting or sustaining human life. Specifically, the postmarket information on AEDs supports increased regulatory review to ensure that device design and manufacturing practices provide a reasonable assurance of safety and effectiveness. FDA acknowledges that the PMA process may result in increased regulatory cost to manufacturers; however, FDA believes that device quality will improve, which will reduce costs associated with postmarket actions including recalls.
FDA also agrees that continued efforts to make safe and effective AED systems available is in the interest of public health, but disagrees that this call for PMAs will limit device availability. FDA believes that many manufacturers of currently marketed AEDs already have, or can reasonably obtain, the necessary data to support a PMA, and hence expects AED distribution to continue to meet demand. Also, for the reasons discussed below, FDA does not intend to enforce compliance with the 90-day deadline for submission of PMAs for currently marketed AEDs and necessary AED accessories.
At the January 2011 Panel meeting, the Panel discussed the impact of FDA regulatory scrutiny on innovation. Various Panel members agreed that the appropriate focus should be on assuring reliability of AEDs and that there was no evidence presented to indicate that a call for PMAs would unduly hinder device innovation (Ref. 1). FDA notes that previous significant innovations for AED systems (e.g., new defibrillation waveforms) have been supported by clinical evidence in the 510(k) process and that under the PMA process this clinical evidence is not expected to significantly change. As was mentioned in the proposed order, FDA anticipates that many AED manufacturers already have sufficient clinical evidence to support a PMA.
SOURCE: Federal Register