Federal Register #2026-13139

FDA Classifies Skin Patch for Hyperhidrosis as Class II Medical Device

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final order regarding the regulatory classification of a skin patch for treating hyperhidrosis. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Candesant Biomedical, Inc. (referenced as the requester for De Novo classification of the NSWEAT Patch) - Products/Services Requested: - Skin patch for treatment of hyperhidrosis - Prescription topical patch - Utilizes a chemical reaction to generate thermal energy in situ - No specific part numbers or quantities provided - Unique or Notable Requirements: - Device classified as a Class II medical device with special controls - Special controls include: - Clinical and non-clinical performance testing - Biocompatibility evaluation - Shelf life testing - Detailed labeling for both patients and physicians - Risk mitigation and instructions for safe disposal - Classification allows future similar devices to use the 510(k) process for market entry - No procurement, solicitation, or award is announced in this notice

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 enhancing patient access to innovative devices by reducing regulatory burdens. The special controls include clinical performance testing, non-clinical performance testing, biocompatibility, shelf life testing, and specific labeling requirements for patients and physicians.

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