LAC 33:XV.747. Use of Sealed Sources in Teletherapy Units, Remote Afterloader Units, and Gamma Stereotactic Radiosurgery Units

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.