3701:1-58-55. 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:

(A) As approved in the Sealed Source and Device Registry; or

(B) 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: 06/12/2015 and 06/01/2020
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 8/15/2005

Prior History: (R.C. 119.032 review dates: 07/12/2010 and 07/12/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 8/15/2005 )