(1) An AED used by an AED program must be a unit approved by the U.S. Food and Drug Administration in accordance with its Final Order established Feb 2015.

(2) A copy of the Final Order referred to in (1) may be obtained from the U.S. Food and Drug Administration: https://www.federalregister.gov/documents/2015/02/03/2015-02049/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems.