(a) Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.

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

(1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm2, r.m.s.), maximum average current (mA), maximum average power density (W/cm2), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.

(2) Software verification, validation, and hazard analysis shall be performed.

(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.

(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).

(5) The labeling must include:

(i) Instructions for proper use of the device, including placement of the device on the patient; and

(ii) Instructions on care and cleaning of the device.

[82 FR 61169, Dec. 27, 2017]