Ohio Admin. Code 3701:1-58-43

Current through all regulations passed and filed through October 28, 2024

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

A licensee shall use only brachytherapy sources:

(A) As approved in the sealed source and device registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the sealed source and device registry, but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry; or

(B) In research to deliver therapeutic doses for medical use 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.

Replaces: 3701:1-58-43

Ohio Admin. Code 3701:1-58-43

Effective: 8/15/2021
Five Year Review (FYR) Dates: 08/15/2026
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005