Section 216-RICR-40-20-5.12 - Other Use of Electronically-Produced Radiation To Deliver Therapeutic Radiation Dosage5.12.1Prohibition on UseA. A person must 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. The applicant or registrant has, at a minimum, provided the Agency with: a. A detailed description of the device and its intended application(s);b. Facility design requirements, including shielding and access control;c. Documentation of appropriate training for Authorized Physician, qualified medical physicist(s) and other personnel who will be involved in performing quality assurance tasks and/or setting up patients for treatment or delivering treatment;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 machine quality assurance radiation safety;f. Radiation safety precautions and instructions; and g. Other information requested by the Agency in its review of the application; and2. 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.216 R.I. Code R. 216-RICR-40-20-5.12
Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/27/2023