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EXTERNAL TRANSCUTANEOUS CARDIAC PACEMAKER DOWNCLASSIFICATION PETITION PROPOSES USER TRAINING, VOLUNTARY STANDARDS AS SPECIAL CONTROLS

This article was originally published in The Gray Sheet

Executive Summary

User training requirements could serve as a special control for external transcutaneous cardiac pacemakers, a consortium of pacemaker firms say in a petition to FDA seeking downclassification of the pre-1976 devices from Class III to Class II. Training would help address the risks of operator-related failure-to-pace error and adverse skin effects caused by pacing electrodes, the group says.
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