FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; NEUROLOGICAL DEVICES; CLASSIFICATION OF THE COMPUTERIZED BEHAVIORAL THERAPY DEVICE FOR THE TREATMENT OF FIBROMYALGIA SYMPTOMS

WASHINGTON, June 26 -- Food and Drug Administration has issued a rule called: Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms.

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 computerized behavioral therapy device for the treatment of fibromyalgia symptoms 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 computerized behavioral therapy device for th...