Fla. Admin. Code R. 64E-5.634

Current through Reg. 50, No. 235-239, December 10, 2024

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.