Florida Regulations 64E-5.634: Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Sterotactic Radiosurgery Unit
Current as of: 2024 | Check for updates
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(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 Fl. Admin. Code R. 64E-5.612 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 Fl. Admin. Code R. 64E-5.612, 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 Fl. Admin. Code R. 64E-5.612, are met.
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. History-New 8-25-91, Formerly 10D-91.751, Amended 2-11-10.
(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 Fl. Admin. Code R. 64E-5.612 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 Fl. Admin. Code R. 64E-5.612, 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 Fl. Admin. Code R. 64E-5.612, are met.
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. History-New 8-25-91, Formerly 10D-91.751, Amended 2-11-10.