21 CFR §886.5305

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.