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In Brief: Apgar timer, lice removal kit, infusion stand downclassification

This article was originally published in The Gray Sheet

Executive Summary

Apgar timer, lice removal kit, infusion stand downclassification: Devices proposed for classification in Class I in a March 10 Federal Register notice. The proposal is in line with a July 1995 recommendation of FDA's General Hospital and Personal Use Devices Panel. The products were inadvertently omitted from the agency's October 1980 classification of other general hospital and personal use devices. Lice removal kits and infusion stands would still be subject to quality systems requirements, FDA says in the notice; Apgar timers would be exempt due to their simple design...
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