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The Food and Drug Administration (FDA) regulates food, medicine, electronics that emit radiation, biological agents, cosmetics, veterinary products, and medical devices. Neuromuscular electrical stimulation devices are most often considered Class II non-exempt medical devices and are therefore subject to FDA regulation. Prior to marketing and selling such a device, the manufacturer must file a premarket notification [510(k)] with the FDA. As part of this 510(k) application, methodology and results of any studies conducted to design a device or determine the use of devices must be described. The FDA determines the safety and effectiveness of a device by reviewing information from these studies.
If premarket approval is granted for a 510(k) application, a device is "cleared to market" by the FDA. This clearance means that the device is substantially equivalent to other similar devices and can be marketed as such. The FDA does not clear or approve specific treatment techniques, only the devices used in the course of such treatment.
— Amy Hasselkus, associate director of health care services in speech-language pathology
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