CDRH Launches AED Initiative in Response to Adverse Events

CDRH is kicking off an industrywide initiative for external defibrillators to tackle the growing number of serious adverse events associated with the emergency-use devices. Part of that initiative includes designating an appropriate approval pathway that promotes best practices for design and testing. The preamendment devices are considered Class III, but some have been cleared through the 510(k) process. CDRH plans to hold an advisory panel meeting in January to discuss which regulatory pathway is best for automatic external defibrillators (AEDs). The center hopes to make a final decision on the classification later next year.
Devices & Diagnostics Letter