In the United States, the Food and Drug Administration (FDA) classifies most AEDs as Class III medical devices that require thorough and rigorous testing for safety. As a Class III medical device, an AED requires a prescription (or medical authorization) at time of purchase since they administer invasive medical therapy.
However, an AED prescription is unlike a prescription for medication because you can’t administer CPR and shock yourself while unconscious; a trained responder is needed to use an AED and to perform CPR.
In addition to the U.S. federal requirement for medical authorization, individual areas and counties may impose requirements for purchasing or owning an AED. Some areas require that the prescribing physician is licensed in the area where the AED will be used. PlusTrac™ not only provides a national medical director to oversee your program, but also local doctors to satisfy specific requirements.