Zdrowie i gospodarka · 05/04/2002

FDA Releases Draft Guidance on Class II Special Controls for Intraoral Devices for Snoring and Obstructive Sleep Apnea

The Food and Drug Administration (FDA) has released a draft guidance document outlining special controls for classifying intraoral devices used to treat snoring and obstructive sleep apnea. The document aims to help manufacturers demonstrate that their devices are substantially equivalent to existing predicate devices.