FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; EAR, NOSE, AND THROAT DEVICES; CLASSIFICATION OF THE TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR THE RELIEF OF CONGESTION

WASHINGTON, April 16 -- Food and Drug Administration has issued a rule called: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion.

The rule was published in the Federal Register on April 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for the relief of congestion 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 classification of the transcutaneous electrical nerve sti...