FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GENERAL AND PLASTIC SURGERY DEVICES; CLASSIFICATION OF THE SKIN PATCH FOR TREATMENT OF HYPERHIDROSIS

WASHINGTON, June 30 -- Food and Drug Administration has issued a rule called: Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis.

The rule was published in the Federal Register on June 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the skin patch for treatment of hyperhidrosis 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 skin patch for treatment of hyperhidrosis. We are taking this action because we have determined that classifyi...