Take note ortho labs - FDA is watching what you are marketing. Recently some labs, specifically orthodontic labs, have received letters from FDA inquiring about the marketing of certain appliances. The appliances that have been scrutinized are Rapid Palatal Expanders (RPEs).
By definition, a medical device is an instrument, apparatus, machine, or implant intended for use in the diagnosis, mitigation, treatment, or prevention of disease. FDA regulates devices based upon their function and how they interact with the body. Generally, Class 1 devices have the least impact on the body and do not stay in the body for extended periods of time. Class II devices are more regulated due to their interaction with the body.
Ortho appliances have been viewed by FDA as patient specific or matched devices prescribed by a licensed practitioner and therefore exempt from registration and listing with FDA. It seems that the scrutiny of the RPEs is due to their function, primarily in children to correct crowding, crossbites, and create space for permanent teeth, while also improving breathing and facial symmetry. They can also be used on adults and it may be that how the appliances are marketing is causing FDA’s interest. As noted, the appliance may improve breathing in children, in adults it may alleviate snoring and possibly sleep apnea. Devices for this purpose are regulated by FDA s Class II medical devices and must have clearance from FDA to market the device. If it appears to FDA that a device is being marketed for a purpose that falls under their classification system, such as airway management, then the agency may contact the lab.
If a lab receives an inquiry from FDA about the marketing of devices, it is most important to respond to the inquiry as quickly as possible even if the lab thinks there is no basis for the inquiry. It is important that the lab be knowledgeable about the regulatory requirements in order to explain the marketing of the appliance. Need help? Contact SafeLink Consulting.
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Learn more about FDA Dental Regulations.