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."

In the Staff Requirements Memorandum (SRM) for SECY-21-0013, “Rulemaking Plan to Establish Requirements for Rubidium-82 Generators and Emerging Medical Technologies,” the Commission approved the initiation of a rulemaking that would address rubidium-82 generators along with all current, well-established emerging medical technologies, plus create added flexibility throughout 10 CFR Part 35 to accommodate future emerging medical technologies. The NRC’s rulemaking plan is publicly available. In addition, in the SRM for SECY-20-0005, “Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35),” the Commission directed the staff to re-evaluate and gather stakeholder feedback on all aspects pertaining to the training and experience requirements for use of emerging medical technologies.

The NRC has started pre-rulemaking activities. An NRC / Agreement State working group has developed a regulatory basis document for the recommended rulemaking. The regulatory basis for SECY-21-0013 will be issued for public comment in 2023, and comments received on the regulatory basis will be considered in the development of the proposed rule. More information about the NRC’s rulemaking process can be found in the NRC’s Rulemaking page. The NRC will use the Medical List Server e-mail to provide updates on the rubidium-82 generators and emerging medical technologies rulemaking as they become available.

NRC Review of Emerging Medical Technologies

In 2020, the NRC instituted a streamlined process for the reviews of emerging medical technologies. The NRC established a Standing Committee composed of NRC and Agreement State staff, to help facilitate early feedback regarding reviews of emerging medical technologies and licensing guidance development. The charter and State Agreement procedure for the Standing Committee for Reviewing Emerging Medical Technologies (SCREMT) are publicly available. The SCREMT meets on an as needed basis to provide feedback on licensing determination for emerging medical technologies, as well as to review and comment on draft licensing guidance documents developed by the NRC.

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)
Alpha Tau Alpha DaRT™ Manual Brachytherapy Licensed under 35.1000 March 2022 Licensing Guidance
Regulatory Guidance Chart
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
GT Medical Technologies Gammatile Licensed under 10 CFR 35.400 August 2019 MEMO: Licensing for Medical Technologies Gammatile
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)
Lutetium-177 Radiopharmaceuticals (Lutathera®, PluvictoTM) Licensed under 35.300 June 2018 Licensing of Lutetium-177
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 December 2021 Licensing Guidance

(Revision 2)

Supersedes the Temporary Addendum and Revision 1
May 2021

Temporary COVID-19 Addendum

January 2020

Licensing Guidance
(Revision 1)

Supersedes:
Feb 2018

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 April 2021

Licensing Guidance
(Revision 10.2)

Supersedes:
March 2020
November 2019
February 2016
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
Xcision® GammaPod™ Licensing Guidance Licensed under 35.1000 January 2020 Licensing Guidance

Page Last Reviewed/Updated Tuesday, November 29, 2022