At the January 26, 2011 meeting of the FDA (Food and Drug Administration) ..., a recommendation emerged to tighten regulation of AEDs (Automatic External Defibrillators). Currently, AEDs are listed as Class III (high risk) medical devices being regulated as Class II (moderate risk) devices due to a grandfathering clause in the rules. Changes in design or new Class II products must undergo a review process referred to as “510 (k)” whereas Class III devices require a much more rigorous Pre-Market Approval (PMA) process. The General Accounting Office (GAO) asked the FDA to either reclassify AEDs as Class II or regulate them as Class III devices. It appears the FDA will pursue the latter.
During the past five years, there have been 68 recalls of AED devices with over 23,000 reports to the FDA of AED malfunctions, some happening during resuscitations where device failure may have contributed to patient deaths. The FDA panel believes that AED manufacturers have failed to remedy problems that have led to the repeated recalls. With up to 2 million AEDs presently deployed in the US, the decision could be costly to manufacturers. A 510(k) review costs approximately $4,000 for a large manufacturer while a PMA application fee runs upwards of $236,000.
If the FDA decides to classify AEDs as Class III devices and require PMA for new models and designs, it may well push some of the less credible manufacturers and fly-by-night models right off the market. Stay tuned for a final decision.