FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; NEUROLOGICAL DEVICES; CLASSIFICATION OF FIELD GENERATOR POSITIONING DEVICE

WASHINGTON, Nov. 26 -- Food and Drug Administration has issued a rule called: Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device.

The rule was published in the Federal Register on Nov. 26 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 field generator positioning device into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial inn...