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; or
(b) In research 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

Tenn. Comp. R. & Regs. 0400-20-07-.51
Original rule filed February 22, 2012; effective May 22, 2012.

Authority: T.C.A. ยงยง 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.

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