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Sleep apnea

This article was originally published in The Gray Sheet

Executive Summary

Polysomnographic data should be collected to support an intended use for obstructive sleep apnea, FDA recommends in an 1April 5 special controls draft guidance for intraoral devices for snoring and/or sleep apnea. The draft guidance accompanies a 2proposed rule that seeks to categorize the unclassified preamendments devices as Class II with special controls. Comments on the guidance and proposed rule are due by July 5...
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