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ARRHYTHMIA DETECTION/ALARM DEVICE CLASS II CONSIDERATION RECOMMENDED

This article was originally published in The Gray Sheet

Executive Summary

ARRHYTHMIA DETECTION/ALARM DEVICE CLASS II CONSIDERATION RECOMMENDED by the Health Industry Manufacturers Association in comments on FDA's proposed strategy to call for premarket approval applications for remaining preamendment Class III devices. In an Aug. 31 letter written for HIMA by the Washington, D.C. law offices of King & Spaulding, the association says FDA should include the devices with those the agency thinks have "a high potential for reclassification."

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