Text

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

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

Acronyms