Louisiana Administrative Code
Title 33 - ENVIRONMENTAL QUALITY
Part XV - Radiation Protection
Chapter 7 - Use of Radionuclides in the Healing Arts
Section XV-747 - Use of Sealed Sources in Teletherapy Units, Remote Afterloader Units, and Gamma Stereotactic Radiosurgery Units
Universal Citation: LA Admin Code XV-747
Current through Register Vol. 50, No. 9, September 20, 2024
A. A licensee shall use sealed sources in teletherapy units, photon emitting remote afterloader units, or gamma stereotactic radiosurgery units for therapeutic medical uses:
1. as approved in the Sealed
Source and Device Registry; or
2.
in research in accordance with an active Investigational Device Exemption (IDE)
application accepted by the FDA, provided the requirements of LAC 33:XV.713.A.1
are met.
B. A licensee shall use teletherapy units, photon-emitting remote afterloader units, or gamma stereotactic radiosurgery units:
1. approved
in the Sealed Source and Device Registry to deliver a therapeutic dose for
medical use. These devices may be used for therapeutic medical treatments that
are not explicitly provided for in the Sealed Source and Device Registry, but
shall be used in accordance with radiation safety conditions and limitations
described in the Sealed Source and Device Registry; or
2. in research in accordance with an active
Investigational Device Exemption (IDE) application accepted by the FDA provided
the requirements of LAC 33:XV.713.A.1 are met.
AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.
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