Use of Sealed Sources for Brachytherapy

Section 335 Section 335.7010  Use of Sealed Sources for  Brachytherapy A licensee shall use only brachytherapy sources for therapeutic medical uses: a)         That are: 1)         Obtained from a person specified in Section 335.35, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; and 2)         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)         That are used 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 Section 335.35 are met.