§ 35.400 Use of sources for manual brachytherapy.

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.