FDA Might Reclassify Automated External Defibrillators
Before 2012 is out, the Food and Drug Administration will likely decide whether or not automated external defibrillators should be designated as a Class III medical device, which would mean that the items would be considered high-risk and required to conform to more stringent approval procedures. Previously, a grandfather clause allowed such devices to maintain Class II classification, which means pre-market approval was not necessary as it would be with the Class III designation. The Government Accounting Office first requested the new designation, and an advisory panel followed suit at the beginning of 2011. Certain safety organizations and device manufacturers oppose the potential move, citing high costs and an apparent impact on availability should such a measure pass.
Follow this link for more about the upcoming decision.