ML24325A439
| ML24325A439 | |
| Person / Time | |
|---|---|
| Issue date: | 12/10/2024 |
| From: | Adelaide Giantelli NRC/NMSS/DMSST/MSEB |
| To: | State of CT, State of IN, State, Agreement States |
| Shared Package | |
| ML24325A436 | List: |
| References | |
| Download: ML24325A439 (1) | |
Text
ALL AGREEMENT STATES, CONNECTICUT, AND INDIANA
SUBJECT:
NOTIFICATION OF ISSUANCE OF EYE90 MICROSPHERES LICENSING GUIDANCE (STC-24-065)
Purpose:
To inform the Agreement States, Connecticut, and Indiana that the U.S. Nuclear Regulatory Commission (NRC) issued the Eye90 microspheres Licensing Guidance.
Background:
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, 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). provides the final 10 CFR 35.1000 licensing guidance for Eye90 microspheres (ML24247A254). 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. 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 Eye90 microspheres. 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).
POINT OF CONTACT: Sarah Spence E-MAIL: sarah.spence@nrc.gov TELEPHONE:
(301) 415-3697 December 10, 2024
If you have any questions regarding this correspondence, please contact me at (301) 415-3521 or the individual named below:
Sincerely, Adelaide Giantelli, Chief State Agreement Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. Eye90 microspheres Licensing Guidance
- 2. Consolidated Technical Analysis Signed by Giantelli, Adelaide on 12/10/24
ML24325A436; Ltr ML24325A439 OFFICE NMSS/MSST/MSEB NMSS/MSST
/MSEB NMSS/MSST/MSEB NMSS/MSST/SMPB NAME SSpence KTapp CEinberg AGiantelli DATE Dec 2, 2024 Dec 4, 2024 Dec 5, 2024 Dec 10, 2024