ML25050A096
| ML25050A096 | |
| Person / Time | |
|---|---|
| Issue date: | 04/02/2025 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Monica Ford, Robert Orlikowski, Michelle Simmons NRC/RGN-III, NRC Region 4, NRC Region 1 |
| Shared Package | |
| ML25050A098 | List: |
| References | |
| Download: ML25050A096 (1) | |
Text
.
MEMORANDUM TO:
Monica Ford, 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 Simmons, Acting 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:
LICENSING FOR REFLEXION MEDICAL RADIOTHERAPY SYSTEM On February 1, 2023, the RefleXion Medical Radiotherapy System (RMRS) received De Novo marketing approval from the U.S. Food and Drug Administration. RMRS is a machine used for biology guided radiation therapy (BGRT) to treat primary or metastatic tumors of the bone and lung with external beam therapy. RMRS treats tumors using a linear accelerator and includes an onboard fan beam computed tomography (CT) and two integrated positron emission tomography (PET) arcs. PET imaging, which utilizes F-18 and other PET isotopes, is used to guide the linear accelerator when treating the tumor volume, providing real-time information about tumor movement to optimize tumor dose and limit dose to healthy tissue. The device is also able to function independently as a traditional linear accelerator in the event tumor uptake is insufficient for BGRT.
While RMRS is nominally a therapeutic device, the U.S. Nuclear Regulatory Commission (NRC)-regulated activities associated with the device are diagnostic in nature (i.e., localization).
Upon evaluating the RMRS, the NRC staff recommended to the joint NRC/Agreement State Standing Committee for Reviewing Emerging Medical Technologies (Standing Committee) that the use of F-18 and other RMRS PET isotopes be licensed under 10 CFR Part 35, Subpart D.
CONTACT: Sarah L. Spence, NMSS/MSST (301) 415-3697 April 2, 2025 Signed by Einberg, Christian on 04/02/25
M. Ford, et al.
2 The staff made this recommendation as it found the use of RMRS PET isotopes for NRC-regulated diagnostic, localization purposes is addressed in regulations contained in 10 CFR Part 35, Subpart D. The isotope use further shares radiation concerns with other uses of diagnostic radiopharmaceuticals for localization as shown in the attached Consolidated Technical Analysis, which lists the existing regulatory requirements for use of PET isotopes and identifies that the use for RMRS is the same. The Standing Committee agreed with the staffs recommendation and determined use of RMRS PET isotopes should be licensed under 10 CFR 35.200. If the NRC becomes aware of future developments related to the medical use of RMRS that may impact radiation safety, the NRC and the Standing Committee will revisit this licensing decision.
Because RMRS will be licensed under 10 CFR Part 35 Subpart D, NUREG-1556, Volume 9, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, provides the guidance for licensing. License reviewers and licensees are further directed to the attached Consolidated Technical Analysis which provides specific conditions and regulations which the NRC staff has determined are necessary for the medical use of RMRS PET isotopes.
Notably, 10 CFR 35.200 covers the Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required. Under NRC regulations, the term written directive is defined in 10 CFR 35.2 and pertains to a written order as specified in 10 CFR 35.40. Some state regulatory bodies of machine-produced radiation sources may utilize the term written directive differently to refer to the prescription or treatment plan for machine-produced external beam therapy. For RMRS, a written directive as defined by NRC regulations is not required for administration of the localization radiopharmaceutical, and therefore 10 CFR 35.200 applies.
Further, licensees must have an Authorized User for use of 10 CFR 35.200 who meets the requirements listed in 10 CFR 35.290. Physicians prescribing and overseeing treatment with RMRS are likely to be Authorized Users for therapeutic modalities (e.g., 10 CFR Part 35, Subparts F and H). However, authorization for therapeutic modalities alone does not meet the necessary NRC requirements. Similarly, the use of RMRS PET isotopes implicates the same NRC regulations as traditional PET imaging and localization, including package receipt, dose measurement, calibration, area surveys, and occupational dose monitoring. Licensees should refer to NUREG-1556, Volume 9 for further guidance on complying with these regulations as well.
Enclosure:
Consolidated Technical Analysis
ML25050A098; Memo ML25050A096 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST/MSEB NAME SSpence KTapp CEinberg DATE Feb 20, 2025 Feb 20, 2025 Apr 2, 2025