Muscle Monitoring Devices; Decision Not to Rely on Dental Products Panel Recommendations

Streszczenie

The Food and Drug Administration (FDA) is announcing that it does not intend to rely on recommendations arising out of the October 13 and 14, 1994, meeting of the Dental Products Panel of the Medical Devices Advisory Committee concerning the classification of muscle monitoring devices. It is FDA's view that the October 1994 meeting was flawed and should not be the basis for decisions made about the use of these devices. FDA plans to fully and comprehensively consider the classification of muscle monitoring devices at a future meeting of the Dental Products Panel of the Medical Devices Advisory Committee.