---
kind: "section"
citation: "21 C.F.R. § 886.5305"
title: "21"
number: "886.5305"
heading: "Electromechanical tear stimulator."
url: "https://uscodex.org/cfr/21/886.5305"
---

# §886.5305. Electromechanical tear stimulator.

- (a) **Identification.** An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
    - (i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
    - (ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
    - (iii) **Use life testing.**
  - (3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
  - (4) All patient-contacting components of the device must be demonstrated to be biocompatible.
  - (5) Software verification, validation, and hazard analysis must be performed.
  - (6) Physician and patient labeling must include:
    - (i) A detailed summary of the device's technical parameters;
    - (ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
    - (iii) Information related to electromagnetic compatibility classification;
    - (iv) Instructions on how to clean and maintain the device;
    - (v) A summary of the clinical performance testing conducted with the device;
    - (vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
    - (vii) **Information on how the device operates and the typical sensations experienced during treatment.**

## Notes

### Amendments

[87 FR 9243, Feb. 18, 2022]

### Authority

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

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[87 FR 9243, Feb. 18, 2022]