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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Hako-Med petition: Honolulu firm's April 23 petition requesting that low-voltage electrode lead wires in the vacuum hose of the VacuPulls/VasoPulse be exempted from the performance standard for electrode lead wires and patient cables (21 CFR 898) is denied by FDA. "In this instance, the public health derives no benefit from the continued use of non-compliant electrode lead wires that is not already provided by equivalent powered muscle stimulator and powered peripheral nerve stimulator devices that use compliant electrode wires," the agency writes in the Aug. 30 denial letter. "The continued marketing of unprotected electrode leads and patient cables, no matter how they are labeled, presents an unreasonable and substantial risk of illness or injury to individuals"...
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