FDA Final Rule on Classification of Intraoral Devices

The Food and Drug Administration has announced its final rule that changes the classification of intraoral devices for the treatment of snoring and obstructive sleep apnea to Class II (special controls). This rule is effective December 12, 2002.

Formerly, these appliances remained unclassified as medical devices by the FDA. According to Dr. Susan Runner, of the Center for Devices and Radiological Health, the regulation will help increase the legitimacy of oral appliance therapy for the treatment of sleep disordered breathing.

This may also add to the recognition of oral appliances by insurance providers, thus increasing the possibility for reimbursement to practitioners performing these procedures.

Class II refers to medical devices requiring special controls in order to ensure public health and safety, such as intraoral soreness, TMD, obstruction of oral breathing, loosening or flaring of lower teeth, general tooth movement, and others defined by a FDA Guidance Document. Mandating these considerations will add medical validity to the use of these appliances and significantly reduce the number of unmitigated devices.

Dental laboratories expressed concern over the Guidance Document, however labs currently conform to these rules. This ruling will not alter their regulatory requirements. Dr. Harold A. Smith, President of the Academy of Dental Sleep Medicine, states, "The FDA classification of oral devices is a forward step in the future of oral appliance therapy, but more importantly,
will ensure the effective treatment and overall health of patients."

For more information regarding the FDA regulation on medical devices, a copy of the FDA Guidance Document, or a list of devices currently cleared by the FDA, please visit the Academy of Dental Sleep Medicine's Web site: www.dentalsleepmed.org.