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Device reclassifications

This article was originally published in The Gray Sheet

Executive Summary

Cardiopulmonary bypass accessory equipment (21 CFR 870.4200) that involves an electrical connection to the patient, goniometer devices (888.1500) and electrode cables (890.1175) would be reclassified from Class I to Class II under an Aug. 9 FDA proposed rule. The products likewise would be exempted from 510(k) requirements, FDA says. Cardiopulmonary bypass accessory equipment that does not involve electrical connection to the patient would remain in Class I and be 510(k)-exempt. Special controls for all three devices would be FDA's performance standard for electrode lead wire and patient cables and the agency's guidance document for complying with the standard. Comments on the proposal are due Nov. 8
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