Subpart F--Manual Brachytherapy
§ 35.400 Use of sources for manual brachytherapy.
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.