A licensee must use only brachytherapy sources:
(a) Approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or
(b) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.
[83 FR 33109, July 16, 2018]
authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 223, 234, 274 (
42 U.S.C. 2111,
2201,
2231,
2232,
2233,
2273,
2282,
2021; Energy Reorganization Act of 1974, secs. 201, 206 (
42 U.S.C. 5841,
5846;
44 U.S.C. 3504 note
source: 67 FR 20370, Apr. 24, 2002, unless otherwise noted.
cite as: 10 CFR 35.400