Evaluation of Devices for the Prevention of Sudden Death: Study Design for Safety and Efficacy of the Devices

Abstract

The responsibility of the Circulatory Systems Devices Panel of the Federal Food and Drug Administration is to advise the commissioner on whether the proposed device has been shown, in both in vitro and in vivo testing, to be both reasonably safe and reasonably effective. When a new device such as that proposed to detect potentially fatal arrhythmias and prevent sudden death is developed, there are few precedents available to provide a plan for its evaluation. However, previous devices such as the numerous pacemakers already tested, approved, and in use, give some help in developing plans for the evaluation. Certain aspects of the evaluation, such as material bio-compatibility, fluid tightness of the device container, mechanical flexion characteristics of leads, etc., have already been evaluated when the same materials and configuration were used for devices already tested and approved. Once tested, these components need not be retested to the same extent as was necessary originally.