64E-5.634. Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Sterotactic Radiosurgery Unit

(1) A licensee shall use sealed sources in photon emitting 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 IDE application accepted by the FDA provided the requirements of Rule 64E-5.612, F.A.C. are met. (2) A licensee shall use sealed sources in photon emitting remote afterloader units for therapeutic medical uses: (a) As approved in the Sealed Source and Device Registry, or (b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of Rule 64E-5.612, F.A.C., are met. (3) A licensee shall use sealed sources in photon emitting teletherapy units for therapeutic medical uses: (a) As approved in the Sealed Source and Device Registry, or (b) In research in accordance with an active IDE application accepted by the FDA provided the requirements of Rule 64E-5.612, F.A.C., are met.