As new and emerging technologies continue to define and influence our lives in the 21st Century, regulators must work to ensure that their own efforts reflect the latest technology developments and address potential regulatory and safety concerns.
The case is perhaps most interestingly illustrated by a decision by the U.S. Food and Drug Administration (FDA) regarding its review of an electric toothbrush that uses radiofrequency (RF) waves to remove plaque and stains from teeth. Developed by the company Home Skinovations Limited, the ToothWave™ electric toothbrush uses patented RF technology to direct RF waves to the teeth and gum line. The company claims that the RF waves destabilize impure molecules that bond to teeth and replaces them with new, purer molecules that provide a stronger protective layer.
The company submitted a De Novo classification request regarding the device to the FDA back in 2019. After a year-long extensive review, the FDA classified the toothbrush as a Class II device, that is, a device that requires specific “special controls” to provide reasonable assurances of the safety and effectiveness of the device for its intended use.
In the latest development, the FDA has now modified its regulations under 21 CFR Part 872, adding a “radiofrequency toothbrush” as a regulated device. In a Final Amendment and Final Order issued in early September, the FDA now defines specific requirements applicable to this advanced dental care product that are intended to mitigate potential risks to health associated with the use of such a device.
The complete text of the FDA’s Final Order regarding the classification of radiofrequency toothbrushes as published in the Federal Register is available at https://www.federalregister.gov/documents/2024/09/05/2024-19868/medical-devices-dental-devices-classification-of-the-radiofrequency-toothbrush.
