1. (a) Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.

2. (b) Classification. Class II (special controls). The special controls for this device are:

   1. (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. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:

      1. (i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
      2. (ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
      3. (iii) Use life testing.
   3. (3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
   4. (4) All patient-contacting components of the device must be demonstrated to be biocompatible.
   5. (5) Software verification, validation, and hazard analysis must be performed.

   6. (6) Physician and patient labeling must include:

      1. (i) A detailed summary of the device's technical parameters;
      2. (ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
      3. (iii) Information related to electromagnetic compatibility classification;
      4. (iv) Instructions on how to clean and maintain the device;
      5. (v) A summary of the clinical performance testing conducted with the device;
      6. (vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
      7. (vii) Information on how the device operates and the typical sensations experienced during treatment.

[87 FR 9243, Feb. 18, 2022]