ML25050A097
| ML25050A097 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2025 |
| From: | Jennifer Fisher NRC/NMSS/DMSST/MSEB |
| To: | |
| Shared Package | |
| ML25050A098 | List: |
| References | |
| Download: ML25050A097 (1) | |
Text
Consolidated Technical Analysis 1
Enclosure The following table provides a list of 10 CFR Part 35 regulations and conditions the NRC has determined are applicable for use of the Reflexion Medical Radiotherapy System (RMRS). Licensees shall comply with all regulations which address use of RMRS. The table also provides specific conditions which the NRC has determined are necessary for the medical use of RMRS. Applicants may submit alternative list of regulations and specific conditions to be reviewed on a case-by-case basis by NRC staff.
Section Description Use Addressed in Regulation Guidance Comment 35.1 Purpose and scope Yes No N/A 1556 Vol 9 Other 35.2 Definitions Yes No N/A 1556 Vol 9 Other 35.5 Maintenance of records Yes No N/A 1556 Vol 9 Other 35.6 Provisions for the protection of human research subjects Yes No N/A 1556 Vol 9 Other 35.7 FDA, other Federal, and State requirements Yes No N/A 1556 Vol 9 Other 35.8 Information collection requirements: OMB approval Yes No N/A 1556 Vol 9 Other
Consolidated Technical Analysis 2
Enclosure 35.10 Implementation Yes No N/A 1556 Vol 9 Other 35.11 License required Yes No N/A 1556 Vol 9 Other 35.12 Application for license, amendment, or renewal Yes No N/A 1556 Vol 9 Other 35.13 License amendments Yes No N/A 1556 Vol 9 Other 35.14 Notifications Yes No N/A 1556 Vol 9 Other 35.15 Exemptions regarding Type A specific licenses of broad scope Yes No N/A 1556 Vol 9 Other 35.18 License issuance Yes No N/A 1556 Vol 9 Other 35.19 Specific exemptions Yes No N/A 1556 Vol 9 Other Subpart B - General Administrative Requirements 35.24 Authority and responsibilities for the radiation protection program Yes No N/A 1556 Vol 9 Other 35.26 Radiation protection program changes Yes No N/A 1556 Vol 9 Other 35.27 Supervision Yes No N/A 1556 Vol 9 Other 35.40 Written directives (WDs)
Yes No N/A 1556 Vol 9 Other any therapeutic dosage of unsealed byproduct material or any therapeutic dose of radiation from byproduct material. The procedure is therapeutic but the dosage of byproduct material is not.
Consolidated Technical Analysis 3
Enclosure 35.41 Procedures for administrations requiring a WD Yes No N/A 1556 Vol 9 Other 35.49 Suppliers for sealed sources or devices for medical use Yes No N/A 1556 Vol 9 Other 35.50 Training for Radiation Safety Officer (RSO) and Associate RSO Yes No N/A 1556 Vol 9 Other 35.51 Training for an authorized medical physicist (AMP)
Yes No N/A 1556 Vol 9 Other 35.55 Training for an authorized nuclear pharmacist (ANP)
Yes No N/A 1556 Vol 9 Other 35.57 Training for experienced RSO, teletherapy or medical physicist, AMP, authorized user (AU),
nuclear pharmacist, and ANP Yes No N/A 1556 Vol 9 Other 35.59 Recentness of training Yes No N/A 1556 Vol 9 Other Subpart C - General Technical Requirements 35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material Yes No N/A 1556 Vol 9 Other 35.61 Calibration of survey instruments Yes No N/A 1556 Vol 9 Other 35.63 Determination of dosages of unsealed byproduct material for medical use Yes No N/A 1556 Vol 9 Other
Consolidated Technical Analysis 4
Enclosure 35.65 Authorization for calibration, transmission, and reference sources Yes No N/A 1556 Vol 9 Other 35.67 Requirements for possession of sealed sources and brachytherapy sources Yes No N/A 1556 Vol 9 Other 35.69 Labeling of vials and syringes Yes No N/A 1556 Vol 9 Other 35.70 Surveys of ambient radiation exposure rate Yes No N/A 1556 Vol 9 Other 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1556 Vol 9 Other 35.80 Provision of mobile medical service Yes No N/A 1556 Vol 9 Other 35.92 Decay-in-storage Yes No N/A 1556 Vol 9 Other Subpart D - Manual Unsealed Byproduct Material - Written Directive Not Required 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required Yes No N/A 1556 Vol 9 Other 35.190 Training for uptake, dilution, and excretion studies Yes No N/A 1556 Vol 9 Other 35.200 Use of unsealed byproduct material for imaging and localization studies for which a Yes No N/A 1556 Vol 9 Other Reflexion self-describes the purpose of the PET as localization in the workflow leading up to treatment; there is no reason not to consider the intra-therapy PET scans as localization as well.
Consolidated Technical Analysis 5
Enclosure written directive is not required 35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations Yes No N/A 1556 Vol 9 Other 35.290 Training for imaging and localization studies Yes No N/A 1556 Vol 9 Other Subpart E - Unsealed Byproduct Material - Written Directive Required N/A Subpart F - Manual Brachytherapy N/A Subpart G - Sealed Sources for Diagnosis N/A Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units N/A Subpart K - Other Medical Uses of Byproduct Material or Radiation From Byproduct Material N/A Subpart L - Records 35.2024 Records of authority and responsibilities for radiation protection programs Yes No N/A 1556 Vol 9 Other 35.2026 Records of radiation protection program changes Yes No N/A 1556 Vol 9 Other 35.2040 Records of WDs Yes No N/A 1556 Vol 9 Other 35.2041 Records for procedure for administrations requiring a WD Yes No N/A 1556 Vol 9 Other 35.2060 Records of calibrations of instruments used to measure the activity of Yes No N/A 1556 Vol 9 Other
Consolidated Technical Analysis 6
Enclosure unsealed byproduct materials 35.2061 Records of radiation survey instrument calibrations Yes No N/A 1556 Vol 9 Other 35.2063 Records of dosages of unsealed byproduct material for medical use Yes No N/A 1556 Vol 9 Other 35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources Yes No N/A 1556 Vol 9 Other 35.2070 Records of surveys for ambient radiation exposure rate Yes No N/A 1556 Vol 9 Other 35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1556 Vol 9 Other 35.2080 Records of mobile medical services Yes No N/A 1556 Vol 9 Other 35.2092 Records of decay-in-storage Yes No N/A 1556 Vol 9 Other 35.2204 Records of Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 1556 Vol 9 Other 35.2404 Records of surveys after source implant and removal Yes No N/A 1556 Vol 9 Other 35.2406 Records of brachytherapy source accountability Yes No N/A 1556 Vol 9 Other 35.2432 Records of calibration measurements of brachytherapy sources Yes No N/A 1556 Vol 9 Other
Consolidated Technical Analysis 7
Enclosure 35.2433 Records of decay of Sr-90 sources for ophthalmic treatments Yes No N/A 1556 Vol 9 Other Subpart M - Reports 35.3045 Report and notification of a medical event Yes No N/A 1556 Vol 9 Other 35.3047 Report and notification of a dose to an embryo/fetus or a nursing child Yes No N/A 1556 Vol 9 Other 35.3067 Report of a leaking source Yes No N/A 1556 Vol 9 Other 35.3204 Report and notification for an eluate exceeding permissible Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 1556 Vol 9 Other Subpart N - Enforcement 35.4001 Violations Yes No N/A 1556 Vol 9 Other 35.4002 Criminal penalties Yes No N/A 1556 Vol 9 Other Additional Considerations
Consolidated Technical Analysis 8
Enclosure
ML25050A098; ML25050A097 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST/MSEB NAME SSpence KTapp CEinberg DATE Feb 20, 2025 Feb 20, 2025 Apr 2, 2025