Current through Register Vol. 48, 12, December 27, 2024
Section 61-63.IV.F.RHA 4.46 - Use of Sources for Manual Brachytherapy4.46.1 A licensee must use only brachytherapy sources: 4.46.1.1 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; or4.46.1.2 In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of RHA 4.19.1 are met.S.C. Code Regs. § 61-63.IV.F.RHA 4.46
Amended by State Register Volume 45, Issue No. 05, eff. 5/28/2021.