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OTC devices

This article was originally published in The Tan Sheet

Executive Summary

Ear, Nose & Throat Devices Panel will meet jointly with the Dental Products Panel of the Medical Devices Advisory Committee on Oct. 6 to "discuss general issues surrounding the prescription use versus over-the-counter use of devices intended to treat snoring or mild to severe obstructive sleep apnea (OSA)," FDA announces in an Aug. 18 Federal Register notice. Panelists will pay special attention to "the ability of the patient to self diagnose and treat OSA [and] the types of clinical data that would be needed to support an OTC intended use." Between 8 am and 8:30, the meeting will be closed to the public; from 8:30 am to 5:30 pm, the public can sit in at the Hilton Washington DC North/Gaithersburg...

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