37.104.616    REQUIREMENTS OF AUTOMATED EXTERNAL DEFIBRILLATORS (AED)

(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. 

History: 50-6-503, MCA; IMP, 50-6-503, MCA; NEW, 1999 MAR p. 1913, Eff. 9/10/99; TRANS, from DHES, 2001 MAR p. 2305; AMD, 2005 MAR p. 2681, Eff. 12/23/05; AMD, 2020 MAR p. 2146, Eff. 11/21/20.