CFR > Title 10 - Energy > CHAPTER I—NUCLEAR REGULATORY COMMISSION > PART 35—MEDICAL USE OF BYPRODUCT MATERIAL > SUBPART F—Manual Brachytherapy (§35.400 to §35.491) > 35.400—Use of sources for 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.