1. Licensing New Medical Technology Megan Shober State of Wisconsin August 27, 2014

2. Novel Radiation Therapy Units MASEP Infini device ViewRay System for Radiation Therapy 2

3. Management Directive 5.3 “It is the policy of the U.S. Nuclear Regulatory Commission to provide Agreement State programs opportunity for early and substantive involvement in the development or formulation of any rule, policy, directive, or guidance document…” 3

4. OAS Responsibility Make recommendations and approve the establishment of NRC/Agreement State working groups. – Makes request to NRC. – Provides Agreement State staff for groups. 4

5. Working Group Formation 5 OAS NRC Charter HQCA WI OH Region III

6. Working Group Input 6 Device Manufacturer Other 35.1000 Guidance 35.600 Licensees ACMUI

7. Guidance Output Leveraged expertise Came to consensus Issued product 7

8. 8 Ask for help Use available resources Balanced staffing Looking Ahead…

9. 9 Questions?

10. Abbreviations NRC: Nuclear Regulatory Commission OAS: Organization of Agreement States MASEP: (not an abbreviation) ACMUI: Advisory Committee on the Medical Use of Isotopes OH: Ohio CA: California WI: Wisconsin HQ: NRC Headquarters 10