---
kind: "section"
citation: "21 C.F.R. § 878.4425"
title: "21"
number: "878.4425"
heading: "Skin patch for treatment of hyperhidrosis."
url: "https://uscodex.org/cfr/21/878.4425"
---

# §878.4425. Skin patch for treatment of hyperhidrosis.

- (a) **Identification.** A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate:
    - (i) Reduction in hyperhidrosis using a validated measure;
    - (ii) All adverse events; and
    - (iii) **Impact of residual chemical on the skin.**
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Thermal reactivity of the active device component(s);
    - (ii) The total energy and energy flux (energy per unit area) of the device that is available to induce heating based on calorimetry; and
    - (iii) **Characterization of the distribution and homogeneity of the chemical(s) on and within the device.**
  - (3) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Performance testing must support the shelf life of the device by demonstrating device functionality and package integrity over the labeled shelf life.
  - (5) Patient and physician labeling must include:
    - (i) A summary of the clinical performance testing conducted with the device;
    - (ii) A listing of known risks including local adverse events, systemic effects, and adverse changes in perspiration; and
    - (iii) **Information about the known duration of effect.**
  - (6) Physician labeling must also include:
    - (i) Instructions for safe disposal of the device; and
    - (ii) **A shelf life.**

## Notes

### Amendments

[91 FR 39463, June 30, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[91 FR 39463, June 30, 2026]