Section 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.Fla. Admin. Code Ann. R. 64E-5.634
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS.
New 8-25-91, Formerly 10D-91.751, Amended 2-11-10.New 8-25-91, Formerly 10D-91.751, Amended 2-11-10.