Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
A licensee shall use sealed sources in photon emitting remote
afterloader units, teletherapy units, or gamma stereotactic radiosurgery units
for therapeutic medical uses:
approved in the Sealed Source and Device Registry; or
In research in accordance with an active
investigational device exemption application accepted by the United States food
and drug administration provided the requirements of paragraph (A) of rule
3701:1-58-17 of the
Administrative Code are met.
Five Year Review (FYR) Dates:
Effective Dates: 8/15/2005
Prior History: (R.C.
119.032 review dates:
Effective Dates: 8/15/2005 )