Emerging Medical Technologies

On this page:

• NRC Regulation of Emerging Medical Technologies
• NRC Review of Emerging Medical Technologies
• Status of NRC Review of Emerging Technologies

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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