3701:1-46-49 Registration of product information.

(A) Any manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the director for evaluation of radiation safety information about its product and for its registration.

(B) The request for review must be made in duplicate and sent to the director at the following address:

"Ohio Department of Health

Bureau of Radiation Protection

246 North High Street

Columbus, Ohio 43215"

(C) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(D) The director normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the director formulates reasonable standards and criteria with the help of the manufacturer or distributor. The director shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

(E) After completion of the evaluation, the director issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product.

(F) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

Effective: 12/01/2012
R.C. 119.032 review dates: 09/10/2012 and 09/15/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 10/20/2002, 1/20/08