ML25050A523
| ML25050A523 | |
| Person / Time | |
|---|---|
| Issue date: | 02/28/2025 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Anne Defrancisco, Robert Orlikowski, Michelle Simmons Division of Nuclear Materials Safety I, Division of Nuclear Materials Safety III, Division of Nuclear Materials Safety IV |
| References | |
| Download: ML25050A523 (1) | |
Text
MEMORANDUM TO:
Anne E. DeFrancisco, Chief Medical and Licensing Assistance Branch Division of Nuclear Materials Safety Region I Bob J. Orlikowski, Chief Materials Licensing Branch Division of Nuclear Materials Safety Region III Michelle R. Simmons, Chief Materials Licensing Branch Division of Nuclear Materials Safety Region IV FROM:
Chris E. Einberg, Branch Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Materials Safety and Safeguards
SUBJECT:
NOTIFICATION OF ISSUANCE OF REVISION 1 OF ALPHA TAU ALPHA DARTTM LICENSING GUIDANCE Alpha DaRTTM Revision 1 Licensing Guidance ML24324A433 was published on February 4, 2025.
The initial Alpha Tau Alpha DaRTTM Manual Brachytherapy Licensing Guidance (LG) was issued on March 10, 2022. Due to recently identified events associated with the sterile packaging, the LG was updated to reflect potential Ra-224 and progeny contamination risks with the sealed applicator assembly. Applicator packaging examples can be reviewed in SS&D MA-1426-D-101-S published 20 September 2024.
This updated licensing guidance revision is available under Medical Licensee Toolkit/Emerging Medical Technologies at https://www.nrc.gov/materials/miau/med-use-toolkit/emerg-licensed-med-tech.html. This guidance lists an approved set of regulations and licensing conditions specific to Alpha DaRTTM. The revision includes updates to the following three sections of the LG; (1) device description, (2) surveys, and (3) contamination control. These three sections were updated as a result of detected alpha contamination within or on the inside of the sterile packaging.
February 28, 2025 Signed by Einberg, Christian on 02/28/25
A. DeFrancisco, et al.
2 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. 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.
Memo ML25050A523 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST/MSEB NAME DShaw KTapp CEinberg DATE Feb 19, 2025 Feb 20, 2025 Feb 28, 2025