Section 0400-20-07-.63 - USE OF A SEALED SOURCE IN REMOTE AFTERLOADER UNIT, TELETHERAPY UNIT, OR GAMMA STEREOTACTIC RADIOSURGERY UNIT(1) A licensee must only use sealed sources:(a) As approved in the Sealed Source and Device Registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or(b) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active investigational device exemption (IDE) application accepted by the U.S. Food and Drug Administration (FDA) provided the requirements in paragraph (1) of Rule 0400-20-07-.22 are met.(2) A licensee may only use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:(a) Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but such devices must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or(b) In research in accordance with an active IDE application accepted by the FDA, provided the requirements of paragraph (1) of Rule 0400-20-07-.22 are met.Tenn. Comp. R. & Regs. 0400-20-07-.63
Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.