# 2026-13139: FDA Clears Class II Status for Hyperhidrosis Skin Patch

2026-13139, Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-30, effective 2026-06-30; PRIA reads it as touching household money (as of 2026-07-07).

- Canonical: https://policyrisk.com/federal-register/2026-13139
- As of: 2026-07-07
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-13139
- Title: Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 39461
- Published: 2026-06-30
- Effective: 2026-06-30
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-07-07

## In one line

FDA Clears Class II Status for Hyperhidrosis Skin Patch

## Summary

The FDA is officially classifying the skin patch that treats excessive sweating (hyperhidrosis) as a Class II device, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to this cool new treatment faster and safer, starting June 30, 2026. Companies making these patches will find it easier and less costly to bring their products to market.

## Abstract

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. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- Skin Patch Reclassified to Class II: benefit, medium. The FDA officially classified the skin patch for treating hyperhidrosis as a Class II device with special controls, effective June 30, 2026 (classification applicable April 7, 2023). FDA says this lower-classification reduces regulatory burdens and will enhance patients' access to the treatment.
- De Novo Creates Easier Path For Firms: benefit, medium. FDA used the De Novo process for the N-SWEAT Patch, which means that this device type can serve as a predicate for future devices so other sponsors may use the less-burdensome 510(k) pathway instead of De Novo or premarket approval. FDA issued the De Novo order April 7, 2023 and this classification…
- Device Is Prescription-Only: cost, low. At the time of classification, FDA identifies skin patches for hyperhidrosis as prescription topical patches only. That means you must obtain a prescription from a clinician to use this device.
- Premarket 510(k) Requirement Remains: cost, medium. FDA states that skin patches for treatment of hyperhidrosis are subject to premarket notification under section 510(k) of the FD&C Act because FDA has not exempted this device type under section 510(m).
- Required Safety, Testing, and Labeling Rules: benefit, medium. FDA lists special controls that manufacturers must meet: clinical performance testing (including validated measures of reduction in hyperhidrosis and adverse events), non-clinical thermal and performance testing, biocompatibility, shelf-life testing, and patient and physician labeling that lists ri…

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## Sources
- [2026-13139 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/30/2026-13139/medical-devices-general-and-plastic-surgery-devices-classification-of-the-skin-patch-for-treatment)
- [2026-13139 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-30/pdf/2026-13139.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-13139 (as of 2026-07-07).