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FDA's Dental Products Panel

This article was originally published in The Gray Sheet

Executive Summary

Will re-examine the classification of muscle monitoring devices at its April meeting in response to industry objections. At its October meeting, the panel unanimously recommended that the devices be placed in Class III with high-priority ("The Gray Sheet" Oct. 17, p. 5). Among industry complaints was the charge "that the public was given inadequate notice of the devices that were to be included under the heading of muscle monitoring devices," Panel Executive Secretary Carolyn Tylenda said at the panel's Dec. 7 meeting. An upcoming Federal Register notice will specify that the muscle monitoring devices to be discussed in April are "electronic devices for the diagnosis and/or treatment of temporomandibular disorders, including: jaw tracking devices, sonographic devices, electromyographic devices, and transcutaneous electrical nerve stimulation devices," Tylenda said
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