3701:1-58-43 Use of sources for manual brachytherapy.

A licensee shall use only brachytherapy sources 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 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