Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis

摘要

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 classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. W