Section 0400-20-07-.51 - USE OF SEALED SOURCES FOR MANUAL BRACHYTHERAPY(1) A licensee shall use only brachytherapy sources for therapeutic medical uses:(a) As approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or(b) In research to deliver therapeutic doses for medical use in accordance with an active investigational device exemption (IDE) application accepted by the Food and Drug Administration (FDA) provided the requirements of Rule 0400-20-07-.22 are met.Tenn. Comp. R. & Regs. 0400-20-07-.51
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.