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Electronic Code of Federal Regulations

e-CFR data is current as of May 26, 2020

Title 10Chapter IPart 35Subpart F → §35.400


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
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, July 16, 2018]

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