FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; NEUROLOGICAL DEVICES; CLASSIFICATION OF THE EXTERNAL LOWER EXTREMITY NERVE STIMULATOR FOR RESTLESS LEGS SYNDROME

WASHINGTON, June 26 -- Food and Drug Administration has issued a rule called: Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome.

The rule was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome 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 external lower extremity nerve stimulator for Restless Legs Syndrome. W...