---
kind: "section"
citation: "21 C.F.R. § 882.5896"
title: "21"
number: "882.5896"
heading: "Percutaneous nerve stimulator for substance use disorders."
url: "https://uscodex.org/cfr/21/882.5896"
---

# §882.5896. Percutaneous nerve stimulator for substance use disorders.

- (a) **Identification.** A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
  - (3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) Sterility testing of the percutaneous components of the device must be performed.
  - (6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the specified shelf life.
  - (7) Labeling must include the following:
    - (i) A detailed summary of the device technical parameters;
    - (ii) A warning stating that the device is only for use on clean, intact skin;
    - (iii) Instructions for use, including placement of the device on the patient; and
    - (iv) **A shelf life.**

## Notes

### Amendments

[83 FR 5034, Feb. 5, 2018]

### Authority

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

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[83 FR 5034, Feb. 5, 2018]