SAN FRANCISCO, CA – Under section 201(h) of the Federal Food Drug & Cosmetic Act, Automated External Defibrillators (AEDs) are regulated by the Federal Drug Administration (FDA) and classified as Class III medical devices. Class III devices have the most stringent regulatory controls, but AED units have always been regulated through the 510(k) process, a pre-market pathway that is typically reserved for the far less stringently regulated Class I and Class II devices
Under FDA rules, most AEDs require that purchasers obtain a prescription from a physician. These are usually provided by the AED seller as a matter of course and used as a sales tool. A prescription alone, however, does not satisfy all legal duties in many jurisdictions.