(a) Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.

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

(1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(2) Patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Physician and patient labeling must include:

(i) Summaries of electrical stimulation parameters;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanations of all user-interface components;

(iv) Information related to electromagnetic compatibility classification; and

(v) Instructions on how to clean the device.

[82 FR 60116, Dec. 19, 2017]