Text

Emerging Medical Technologies
	ML23186A027
Person / Time
Issue date:	06/08/2023
From:	Celimar Valentin-Rodriguez; NRC/NMSS/DMSST
To:	;
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	Download: ML23186A027 (1)
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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

OGC

Agreement States

35.1000 Licensing Determination Review use and unique characteristics to determine if EMT can be licensed under other Part 35 Subparts or Subpart K SCREMT Engagement Engage with SCREMT to get early feedback on licensing determination and draft documents EMT Evaluation Evaluate radiation safety aspects of the EMT; T&E; methodology for measurement of doses and dosage; calibration & maintenance; etc.

GUIDANCE Development Develop licensing guidance or licensing memorandum depending on licensing determination STAKEHOLDER Outreach Receive input from NRC Regions, Agreement States, and the ACMUI on draft documents Evaluation & Guidance Development Process

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

Y-90 Microspheres Hepatocellular carcinoma and other cancers Alpha DaRT Solid tumors Liberty Vision Y-90 Disc Sources Episcleral ocular diseases, tumors, and benign growths Brachytherapy

Gamma Stereotactic Radiosurgery Icon, Perfexion, Esprit Tumors, vascular and neurological disorders Akesis Galaxy RTi Cancer and intracranial diseases Xcision GammaPod Breast cancer

Radiopharmaceuticals (§35.300)

LUTATHERA (Lu-177 dotatate)

GEP-NETs PLUVICTO (Lu-177 PSMA)

PSMA-positive mCRPC Xofigo (Ra-223 dichloride)

MCRPC (bone metastasis)

Brachytherapy (§35.400)

GammaTile Brain tumors CivaDerm Skin cancer and other lesions

Feb 2021 Rulemaking Plan Issued Winter 2027 Final Rule EMT/Rb-82 Generator Rulemaking Feb 2022 WG Established Winter 2026 Proposed Rule Summer 2023 Reg Basis to be issued Jan 2022 SRM Issued

Acronyms