(a) Identification. A transcranial magnetic stimulator device for headache is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electrical currents for the treatment of headache.

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

(1) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.

(2) Appropriate verification, validation, and hazard analysis must be performed on the device software and firmware.

(3) The elements of the device that contact the patient must be assessed to be biocompatible.

(4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. This includes full characterization of the magnetic pulse output and resulting magnetic field map. This also includes characterization of the sound level of the device during use.

(5) Clinical testing must demonstrate that the device is safe and effective for treating headache in the indicated patient population.

(6) The physician and patient labeling must include the following:

(i) A summary of the clinical performance testing, including any adverse events and complications.

(ii) The intended use population in terms of the types of headaches appropriate for use with the device.

(iii) Information on how to report adverse events and device malfunctions.

(iv) A diagram or picture depicting the proper placement of the device on the user.

[78 FR 38458, July 8, 2014]