10 C.F.R. § 35.400 Use of sources for manual brachytherapy.
Title 10 - Energy
A licensee shall use only brachytherapy sources for therapeutic medical uses: (a) As approved in the Sealed Source and Device Registry; or (b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of §35.49(a) are met.
Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart F—Manual Brachytherapy
§ 35.400 Use of sources for manual brachytherapy.
