Oral Appliance Therapy
The job of the FDA is to protect consumers and make sure that the benefits of a product outweigh the risks. Their committee on medical devices determined at a meeting in the fall of 1997 that for purposes of treatment, snoring and OSA are considered medical diseases and that all oral appliances for tx of these 'diseases' fall under FDA aegis. The following appliances {class 2} were granted premarket Notification / 510K acceptance which means that they were found to be substantially equivalent to devices marketed before May 28, 1976 and thus allowed to be marketed under the general controls of the Federal Food, Drug and Cosmetic Act rather than requiring specific FDA approval. Appliances which are new in concept {Class 3}, with no prior similar device require Premarket Approval (PMA) by the FDA where submission of full statistical scientific data is required.
The FDA assures:
- Safety
- Performance - does it do what it is supposed to do?
- Effectiveness- is a significant target portion clinically successful?
The FDA accepts OAs ONLY for use in people over 18 years of age.
All oral appliances are mandated to be available by prescription only, not OTC
MANUFACTURERS WILL OFTEN SAY THE APPLIANCE IS FDA ACCEPTED AND NOT SAY THAT IT IS FOR SNORING ONLY!!!
