The FDA is proposing to reclassify AEDs as Class III medical devices. This change will require manufacturers to go through a much more time consuming and costly regulatory process before their AEDs can be sold. Why? According to the agency’s proposed rule, the primary purpose of reclassification is to reduce the risk of illness or injury resulting from AED failures. Yet, a study relied upon by the agency finds that AEDs work as intended during rescue attempts greater than 99% of the time. This is a clear example of the perfect as the enemy of the good (or even great) driving a regulatory action that will cost lives and money with very little public health benefit.

More on this can be found at:
www.readisys.com/aed-reclassification-when-near-perfect-is-not-enough-for-the-fda/