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The U.S. Nuclear Regulatory Commission is in the process of rescinding or revising guidance and policies posted on this webpage in accordance with Executive Order 14151 Ending Radical and Wasteful Government DEI Programs and Preferencing, and Executive Order 14168 Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government. In the interim, any previously issued diversity, equity, inclusion, or gender-related guidance on this webpage should be considered rescinded that is inconsistent with these Executive Orders.

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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