A person shall not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:

1. (a) The applicant or registrant has, at a minimum, provided DHHS/RHS with:

   1. (1) A detailed description of the device and its intended application(s):
   2. (2) Facility design requirements, including shielding and access control;
   3. (3) Documentation of appropriate training for authorized user physician(s) and radiation therapy physicist(s);
   4. (4) Methodology for measurement of dosages to be administered to patients or human research subjects;
   5. (5) Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;
   6. (6) Radiation safety precautions and instructions; and
   7. (7) Other information requested by DHHS/RHS in its review of the application.
2. (b) The applicant or registrant has received approval from DHHS/RHS to utilize the device in accordance with the regulations and specific conditions DHHS/RHS considers necessary for the medical use of the device.

Source. #10894, eff 7-21-15