Zdrowie i gospodarka · 05/04/2002

Dental Devices; Classification for Intraoral Devices for Snoring and/or Obstructive Sleep Apnea

The Food and Drug Administration (FDA) is proposing to classify the intraoral devices for snoring and/or obstructive sleep apnea, used to control or treat simple snoring and/or obstructive sleep apnea. Under the proposal, the intraoral devices for snoring and/or obstructive sleep apnea would be classified into class II (special controls). The agency is publishing in this document the recommendations of the Dental Devices Panel (the Panel) regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these devices. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a draft guidance document that would serve as the special control if this proposal becomes final.