§ 878.4425 — Skin patch for treatment of hyperhidrosis.

§ 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.

[91 FR 39463, June 30, 2026]