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Cardiopulmonary bypass accessories

This article was originally published in The Gray Sheet

Executive Summary

Reclassification from Class I to Class II of cardiopulmonary bypass accessory equipment devices that involve an electrical connection to the patient, as well as goniometer devices and electrode cable devices, is outlined in a final rule published in the April 11 Federal Register. FDA also is exempting the devices from premarket notification requirements, maintaining that general and special controls are adequate to provide reasonable assurance of safety and effectiveness
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