Section 3453. Other use of electronically produced radiation to deliver therapeutic radiation dosage

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

1. The applicant or registrant has, at a minimum, provided the agency with:

a. A detailed description of the device and its intended application;

b. Facility design requirements, including shielding and access control;

c. Documentation of appropriate training for authorized user physicians and qualified medical physicists;

d. Methodology for measurement of dosages to be administered to patients or human research subjects;

e. Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety;

f. Radiation safety precautions and instructions; and

g. Other information requested by the agency in its review of the application; and

2. The applicant or registrant has received written approval from the agency to utilize the device in accordance with the regulations and specific conditions the agency considers necessary for the medical use of the device.

Historical Notes

Derived from Volume 32, Issue 17, eff. June 5, 2016.

Statutory Authority

§§ 32.1-12 and 32.1-229 of the Code of Virginia.