Federal Register #FDA-2026-N-6711

FDA Classifies Skin Patch for Hyperhidrosis and Opioid Oxygenation Monitor as Class II Devices

This notice details the FDA's final rule classifying two medical devices as Class II with special controls: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - OEMs and Vendors: - Candesant Biomedical, Inc. (referenced for the NSWEAT Patch) - Products/Devices: - Skin patch for treatment of hyperhidrosis - Prescription topical patch utilizing a chemical reaction to generate thermal energy in situ - No part number or quantity specified - Developed by Candesant Biomedical, Inc. (NSWEAT Patch) - Monitor for opioid-induced impairment of oxygenation - Device using sensor hardware and software algorithms to detect oxygen desaturation from opioid overdose - No part number or quantity specified - Unique/Notable Requirements: - Both devices require clinical and non-clinical performance testing, biocompatibility evaluation, and specific labeling for patients and physicians - The skin patch also requires shelf life testing - Devices are subject to premarket notification requirements - This is a regulatory classification action, not a procurement or award

Description

The Food and Drug Administration (FDA) is classifying the skin patch for treatment of hyperhidrosis into class II (special controls). This device is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. Special controls include clinical performance testing, non-clinical performance testing, biocompatibility, shelf life testing, and specific labeling requirements.

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