This article was originally published in The Gray Sheet
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be collected to support an intended use for obstructive sleep apnea, FDA recommends in an 1April 5 special controls draft guidance for intraoral devices for snoring and/or sleep apnea. The draft guidance accompanies a 2proposed rule that seeks to categorize the unclassified preamendments devices as Class II with special controls.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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