Link to an amendment published at 83 FR 33109, July 16, 2018.
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.