ML22068A221
| ML22068A221 | |
| Person / Time | |
|---|---|
| Issue date: | 03/14/2022 |
| From: | Brian Anderson Office of Nuclear Material Safety and Safeguards |
| To: | State of CT, State of IN, State, Agreement States |
| K. Tapp, NMSS/MSST/MSEB | |
| Shared Package | |
| ML22068A218 | List: |
| References | |
| STC-22-016 | |
| Download: ML22068A221 (3) | |
Text
March 14, 2022 ALL AGREEMENT STATES, CONNECTICUT, AND INDIANA NOTIFICATION OF ISSUANCE OF ALPHA TAU ALPHA DARTTM MANUAL BRACHYTHERAPY LICENSING GUIDANCE (STC-22-016)
Purpose:
To inform the Agreement States, Connecticut, and Indiana that the U.S. Nuclear Regulatory Commission (NRC) issued the Alpha Tau Alpha DaRTTM Manual Brachytherapy Licensing Guidance.
Background:
Alpha Tau Medical, Inc. Model Alpha DaRTTM series device was conditionally approved by the U.S. Food and Drug Administration in Investigational Device Exemption number G180076, dated May 10, 2018. Alpha DaRTTM are manual brachytherapy sources, with many unique properties that merit radiation safety considerations other than those required by Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Subpart F, Manual Brachytherapy. These unique properties include the recoil release of radon-220 (Rn-220), an alpha emitting noble gas, from the radium-224 (Ra-224) source. As a result, use of Alpha DaRTTM manual brachytherapy sources is regulated under 10 CFR 35.1000, Other Medical Uses of Byproduct Material or Radiation from Byproduct Material. provides the final 10 CFR 35.1000 licensing guidance for Alpha DaRTTM. This guidance lists an approved set of regulations and licensing conditions specific to the Alpha DaRTTM. This guidance should be used in concurrence with NUREG-1556, Volume 9, Revision 3, Consolidated Guidance About Material Licenses: Program-Specific Guidance about Medical Use Licenses, which provides overall licensing guidance for all medical uses of byproduct material. Enclosure 2 provides a supporting technical analysis table which includes a list of 10 CFR Part 35 regulations and conditions the NRC has deemed acceptable for the use of Alpha DaRTTM. However, as stated in the licensing guidance, applicants may submit alternative list of regulations and specific conditions to be reviewed on a case-by-case basis.
The attached licensing guidance will be posted on NRCs public Web site (https://www.nrc.gov/materials/miau/med-use-toolkit/emerg-licensed-med-tech.html).
STC-22-016 2 If you have any questions regarding this correspondence, please contact me at 301-415-3340 or the individual named below:
POINT OF CONTACT: Katie Tapp, Ph.D. E-MAIL: Katherine.Tapp@nrc.gov TELEPHONE: (301) 415-0236 Signed by Anderson, Brian on 03/14/22 Brian C. Anderson, Chief State Agreement Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. Alpha Tau Alpha DaRTTM Manual Brachytherapy Licensing Guidance 2.Consolidated Technical Analysis
Ltr ML22068A221 NMSS/MSST OFFICE NMSS/MSST NMSS/MSST/MSEB NMSS/MSST/SALB
/MSEB CValentin-Rodriguez NAME KTapp KT CEinberg CE BAnderson BA CV DATE Mar 9, 2022 Mar 11, 2022 Mar 11, 2022 Mar 14, 2022