Answer to Question #10039 Submitted to "Ask the Experts"
The following question was answered by an expert in the appropriate field:
We are a start-up company in Israel designing a medical device that contains a sealed source of 192Ir (3.7 x 105 Bq). Are there any storage regulatory restrictions (regarding storage at the company and at the hospitals)? Do we need special protection, a special room, or dose level at the surface?
The best place to start with a new device would be NUREG-1556, Volume 3, Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration.
This document provides assistance to applicants submitting requests to the Nuclear Regulatory Commission (NRC) for radiation safety evaluation and registration of sealed sources and devices containing byproduct material. There is even a section in the volume titled "Sealed Sources and Devices for Medical Use." The manual also has references to NRC's regulatory requirements.
If the company is in a foreign country such as yours, it would not need an NRC license to manufacture the device. To distribute the device, the device would need an evaluation and registration per the NRC or an Agreement State, and the distributor would need a distribution license and would need to have a U.S. address.
The above manual is a good starting point for a start-up company designing a new device.Cynthia G. Jones, PhD