Alert

Due to a lapse in appropriations, the NRC has ceased normal operations. However, excepted and exempted activities necessary to maintain critical health and safety functions—as well as essential progress on designated critical activities, including those specified in Executive Order 14300—will continue, consistent with the OMB-Approved NRC Lapse Plan.

Subpart F—Manual Brachytherapy

§ 35.400 Use of sources for manual brachytherapy.

A licensee must use only brachytherapy sources:

(a) 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 U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.

[83 FR 33109, Jul. 16, 2018]

Page Last Reviewed/Updated Wednesday, January 16, 2019