FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; NEUROLOGICAL DEVICES; CLASSIFICATION OF THE ELECTRICAL TONGUE NERVE STIMULATOR TO TREAT MOTOR DEFICITS

WASHINGTON, Dec. 19 -- Food and Drug Administration has issued a rule called: Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits.

The rule was published in the Federal Register on Dec. 19 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is classifying the electrical tongue nerve stimulator to treat motor deficits into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the electrical tongue nerve stimulator to treat motor deficits. We...