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EXTERNAL DEFIBRILLATOR POSTMARKET SURVEILLANCE STUDIES

This article was originally published in The Gray Sheet

Executive Summary

EXTERNAL DEFIBRILLATOR POSTMARKET SURVEILLANCE STUDIES may be required by FDA. A device center task force, which met for the first time on Nov. 9, is considering requiring postmarket studies in an effort to obtain better data on the safety of automatic external defibrillators. One possible postmarket evaluation protocol is the comparison of different AEDs via blinded physician readings of cardiac events recorded by the devices.
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