Tenn. Comp. R. & Regs. 0400-20-07-.63 - USE OF SEALED SOURCE IN REMOTE AFTERLOADER UNIT, TELETHERAPHY UNIT, OR GAMMA STEREOTACTIC RADIOSURGERY UNIT

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(1) A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units 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 in paragraph (1) of Rule 0400-20-07-.22 are met.

Notes

Tenn. Comp. R. & Regs. 0400-20-07-.63

Original rule filed February 22, 2012; effective May 22, 2012.

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

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