ML24325A475
| ML24325A475 | |
| Person / Time | |
|---|---|
| Issue date: | 11/25/2024 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Anne Defrancisco, Robert Orlikowski, O'Keefe N NRC Region 1, NRC/RGN-III, NRC Region 4 |
| References | |
| Download: ML24325A475 (1) | |
Text
MEMORANDUM TO:
Anne DeFrancisco, Chief Medical and Licensing Assistance Branch Division of Nuclear Materials Safety Region I Bob Orlikowski, Chief Materials Licensing Branch Division of Nuclear Materials Safety Region III Neil F. OKeefe, Chief Materials Licensing Branch Division of Nuclear Materials Safety Region IV FROM:
Chris 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 EYE90 MICROSPHERES LICENSING GUIDANCE The Eye90 microspheres Licensing Guidance (ML24247A254) was published on September 27, 2024.
On May 30, 2023, ABK Biomedical, Inc. announced it had received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for Eye90 microspheres. Eye90 microspheres are radiopaque yttrium-90 (Y-90) glass microspheres used for treatment of conditions of the liver. Similar to existing microsphere technologies, Eye90 microspheres are licensed under Title 10 of the Code of Federal Regulations (10 CFR) Part 35.1000, Subpart K, Other Medical Uses of Byproduct Material or Radiation from Byproduct Material. Like other Y-90 microsphere technologies, Eye90 microspheres are delivered under fluoroscopy guidance. The radiopacity of the microspheres allows for imaging under fluoroscopy during treatment or after treatment using any X-ray imaging technique. As the use of Eye90 microspheres requires use of non-licensed sources of radiation, licensees should remain aware of the occupational monitoring requirements for exposure from licensed and non-licensed sources. More information can be found in IN 2021-02 (ML21152A239).
My staff developed licensing guidance for the Eye90 microspheres. This licensing guidance is available under Medical Licensee Toolkit/Emerging Medical Technologies at November 25, 2024 Signed by Einberg, Christian on 11/25/24
A. DeFrancisco, et al.
2 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 the Eye90 microspheres. 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 ML24325A475 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB NAME KTapp CEinberg DATE Nov 22, 2024 Nov 25, 2024