Panel: AEDs Should Stay Class III and Be Subject to the PMA Path

In a move that could cost devicemakers millions of dollars, an FDA advisory panel has backed the agency’s proposal to classify automated external defibrillators (AEDs) as Class III devices that must go through the PMA process. While no official vote was taken at last week’s meeting of the Circulatory Devices Panel, nearly all of the members said the devices should not be downgraded to Class II. The decision could have a broad impact that stretches beyond the cardiac device industry, Burke Barrett, vice president of regulatory and clinical affairs at CardioFocus and the panel’s industry representative, said.
Devices & Diagnostics Letter