FDA looks at snoring/apnoea devices:
This article was originally published in Clinica
Executive Summary
The US FDA has scheduled a meeting of its Ear Nose and Throat Devices advisory panel and its Dental Products advisory panel to discuss general issues surrounding the prescription use versus the over-the-counter use of devices intended to treat snoring or mild to severe obstructive sleep apnoea. The discussion will include the role of the medical/dental provider in the diagnosis, treatment and follow-up of snoring and OSA; the ability of the patient to self diagnose and treat OSA; the types of clinical data that would be needed to support an over the counter indication and the components of adequate device labelling. The panels will not discuss continuous positive airway pressure devices and surgical treatments for sleep apnea. The meeting will take place on October 6 in Gaithersburg, Maryland