United States Nuclear Regulatory Commission - Protecting People and the Environment

Emerging Medical Technologies

This website provides licensing guidance for emerging medical technologies. The licensing guidance consists of general licensing considerations, specific radiation safety aspects of the emerging medical technology, and training and experience expectations for those authorized to use the emerging medical technology. This website may also help stakeholders who are developing new methods and technologies that may one day be used to treat medical patients. It also contains a record of the emerging medical technologies whose use has been evaluated for licensing by the NRC. Contact Us to submit medical-related inquiries.

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NRC Regulation of Emerging Medical Technologies

Title 10 of the Code of Federal Regulations Part 35, Subpart K – Other Medical Uses of Byproduct Material or Radiation From Byproduct Material (10 CFR 35.1000) describes the process to obtain a license, or an amendment to a license, for a new medical use of byproduct material or radiation from byproduct material, which is not addressed in other parts of 10 CFR Part 35 (i.e., an emerging medical technology).  Additional requirements are included in 10 CFR 35.12(d), "Application for license, amendment, or renewal."

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Status of NRC Review of Emerging Technologies

Below is an Emerging Technologies Table: a current list of emerging technologies, status, and links to corresponding documents.

Note: New entries will be added as additional emerging technologies are identified. Licensing guidance will be updated when necessary to address comments from stakeholders. To submit comments on or inquire about a specific licensing guidance document, contact the individual listed in that document or contact us using our electronic form.  If applicable, you can also contact the appropriate NRC Regional Office or Agreement State for assistance.

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Emerging Technologies
Technology Name Status Document
Date
Document(s)
Best Vascular, Inc. Beta-Cath Intravascular Brachytherapy (IVB) System Licensed under 35.1000 August 2006 Licensing Guidance
Germanium-68/Gallium-68 Pharmaceutical Grade Generators Licensing Guidance Licensed under 35.1000 July 2019 Licensing Guidance
I-125 Iotrex Liquid Brachytherapy Source in Cytyc GliaSite Radiation Therapy Systemm Licensed under 35.1000 August 2006 Licensing Guidance
Low Activity Radioactive Seeds Used for Localization of Non-Palpable Lesions and Lymph Nodes Licensing Guidance Licensed under 35.1000 October 2016 Licensing Guidance

Supersedes:
Sept 2006
Leksell Gamma Knife® Perfexion™ and Leksell Gamma Knife® Icon™ Licensed under 35.1000 January 2019 Licensing Guidance

Supersedes:
May 2016
July 2007 (Perfexion only)
NeoVista, Inc's Epi-Rad90 (Sr-90) Ophthalmic System Licensed under 35.1000 April 2009 Licensing Guidance
NorthStar Medical Radioisotopes, LLC RadioGenix™ Molybdenum-99/Technetium-99m Generator System Licensing Guidance for Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies Licensed under 35.1000 and 10 CFR 30.33 February 2018 Licensing Guidance
Nucletron seedSelectron® System, Isotron Brachytherapy Sources and Nucletron FIRST™ System Retracted N/A N/A
Radium-223 Dichloride Licensed under 35.300 January 2013 MEMO: Licensing for Ra-223 Dichloride
TheraSphere and SIRSpheres Yttrium-90 Microspheres Licensed under 35.1000 October 2017

Draft for Comment Only

Licensing Guidance

Supersedes:
June 2012
Oct 2011
Jan 2011
Sept 2008
Aug 2008
Dec 2007
Sept 2007
Jan 2004
Oct 2002

ViewRay System for Radiation Therapy Licensed under 35.1000 July 2013 Licensing Guidance

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Page Last Reviewed/Updated Tuesday, August 13, 2019