ML23186A027
ML23186A027 | |
Person / Time | |
---|---|
Issue date: | 06/08/2023 |
From: | Celimar Valentin-Rodriguez NRC/NMSS/DMSST |
To: | |
References | |
Download: ML23186A027 (1) | |
Text
Emerging Medical Technologies Celimar Valentin-Rodriguez, PhD Medical Team Leader US Nuclear Regulatory Commission June 8, 2023
Outline Regulatory Background Guidance Development Process Emerging Medical Technologies Rulemaking
EMT Regulatory Background
- In 2002, the Commission added 10 CFR 35.1000 to add generic requirements for new medical uses of byproduct material or radiation from byproduct material (EMTs)
- 10 CFR 35.1000 allows the NRC and Agreement States to regulate medical uses that are not otherwise addressed in 10 CFR Part 35 on a case-by-case basis
Standing Committee on Reviewing Emerging Medical Technologies
- Established in 2020
- Assist NRC staff in evaluating the licensing of EMTs and provide early feedback on draft documents
- Includes members from
- MRST
- NRC Regions
- Agreement States
Evaluation & Guidance Development Process EMT Evaluation STAKEHOLDER Outreach Evaluate radiation safety aspects of the EMT; T&E; Receive input from NRC methodology for measurement Regions, Agreement States, of doses and dosage; and the ACMUI on draft calibration & maintenance; etc.
documents 35.1000 Licensing Determination Review use and unique characteristics to determine if EMT can be licensed under other GUIDANCE Development Part 35 Subparts or Subpart K Develop licensing guidance or licensing memorandum SCREMT Engagement depending on licensing Engage with SCREMT to get determination early feedback on licensing determination and draft documents
EMT Evaluations
- Since 2002
- reviewed more than 16 EMTs
- issued 12 licensing guidance documents
- issued 3 licensing memoranda
- Licensing guidance is revised as needed, as we gain operating experience with EMTs
Brachytherapy Y-90 Microspheres Alpha DaRT Liberty Vision Y-90 Disc Sources Hepatocellular carcinoma Solid tumors Episcleral ocular diseases, and other cancers tumors, and benign growths
Gamma Stereotactic Radiosurgery Icon, Perfexion, Esprit Akesis Galaxy RTi Xcision GammaPod Tumors, vascular and Cancer and intracranial Breast cancer neurological disorders diseases
Radiopharmaceuticals (§35.300)
LUTATHERA PLUVICTO Xofigo (Lu-177 dotatate) (Lu-177 PSMA) (Ra-223 dichloride)
GEP-NETs PSMA-positive mCRPC MCRPC (bone metastasis)
Brachytherapy (§35.400)
GammaTile CivaDerm Brain tumors Skin cancer and other lesions
EMT/Rb-82 Generator Rulemaking Jan 2022 Summer 2023 Winter 2027 SRM Issued Reg Basis to be issued Final Rule Feb 2021 Feb 2022 Winter 2026 Rulemaking Plan Issued WG Established Proposed Rule
- CFR - Code of Federal Regulations
- PSMA - prostate-specific
- EMT - emerging medical membrane antigen technology(ies)
- GEP-NETs - gastroenteropancreatic
- Rb rubidium-82 neuroendocrine tumors
- OGC - Office of the General
- Lu-177 - lutetium-177 Counsel
- MRST - Medical Radiation Safety
- SRM - staff requirements Team memorandum
- mCRPC - metastatic castration-
- WG - working group resistant prostate cancer
Contact Us!
Celimar.Valentin-Rodriguez@nrc.gov medicalquestions.resource@nrc.gov 301-415-7124 Medical Uses Licensee Toolkit l NRC Public Website