Tenn. Comp. R. & Regs. 0400-20-07-.51 - USE OF SEALED SOURCES FOR MANUAL BRACHYTHERAPY
(1) A licensee shall use only brachytherapy
sources for therapeutic medical uses:
(a) As
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 Food and Drug Administration
(FDA) provided the requirements of Rule
0400-20-07-.22 are
met.
Notes
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