In 2011 FDA began an initiative to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices, and urge industry to address current practices for identifying, reporting, and acting on the device complaints. FDA’s External Defibrillator Improvement Initiative, which is further highlighted in the White Paper, will:
1. Promote innovation of next generation external defibrillators to improve safety and effectiveness
To promote innovation and better understand patient outcomes, the FDA is collaborating with the University of Colorado’s Department of Emergency Medicine to develop a multi-city AED registry that will collect information about AED usage and provide the infrastructure to allow development of innovative AED features such as automated integration into local 9-1-1 systems.
FDA hosted a public workshop on December 15 - 16, 2010, with multiple stakeholders to facilitate the development of next-generation defibrillators, enhance surveillance of defibrillators in community settings, and improve the rapid delivery of treatment for sudden cardiac arrest patients.
FDA sent a letter to all manufacturers of external defibrillators encouraging them to meet with the agency early in the device development process to discuss ways in which they can avoid common problems in the design and manufacturing of these devices.
2. Enhance the ability of industry and the FDA to identify and respond to problems with devices currently on the market to address potential safety risks more quickly and effectively
FDA is working with device manufacturers to improve current industry practices for handling user complaints, reporting adverse events, failure analysis of device malfunctions, conducting recalls, and communicating with users.
3. Designate an appropriate premarket regulatory pathway for AEDs that promotes best practices for design and testing.
The FDA classifies medical devices into one of three categories based on the level of control necessary to provide reasonable assurance of safety and effectiveness. The classification process is a risk-based process that allows the FDA to apply the appropriate level of regulatory oversight before devices are marketed. Class III devices are those requiring the greatest level of control due to their life-saving impact, their potential for injury, or lack of information about how to control the device’s risks.
Automated external defibrillators (AEDs) were given a Class III designation when they were determined to be substantially equivalent to similar Class III devices that were on the market prior to the 1976 Medical Device Amendments. They have always been regulated through the 510(k) process, a premarket pathway that is typically reserved for Class I and Class II devices, but which has also been used for some Class III devices that were allowed to be reviewed under the 510(k) regulations until reclassified or determined to require a PMA.
According to a 1990 amendment to the 1976 legislation, the FDA must either down-classify AEDs to Class II or keep AEDs as Class III and require they go through the more stringent Premarket Approval (PMA) process. The FDA is now proceeding with the formal classification of AEDs. In January, 2011, the FDA convened an advisory panel meeting to discuss which of these regulatory pathways is more appropriate for AEDs to provide reasonable assurances of safety and effectiveness for these devices.