§ 35.400 - Use of sources for manual brachytherapy.

§ 35.400 Use of sources for manual brachytherapy.

Cross Reference

Link to an amendment published at 83 FR 33109, July 16, 2018.

A licensee shall must use only brachytherapy sources for therapeutic medical uses:

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

[83 FR 33109, July 16, 2018]