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ARE ORAL APPLIANCES TO TREAT OBSTRUCTIVE SLEEP APNEA AND SNORING APPROVED BY THE FOOD AND DRUG ADMINISTRATION?

April 26, 2017Apnea appliances Approved Food and Drug Administration obstructive oral sleep Snoring treat

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ARE ORAL APPLIANCES TO TREAT OBSTRUCTIVE SLEEP APNEA AND SNORING APPROVED BY THE FOOD AND DRUG ADMINISTRATION?

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Yes. Oral appliances for the treatment of snoring and obstructive sleep apnea require FDA clearance before they may be marketed. As such, they are considered to be medical devices under the definition of the Food, Drug and Cosmetic Act, Sec. 201 (h) of the Act.