Emerging Medical Technologies
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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.
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Rulemaking: 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.
Rulemaking Schedule and Public Involvement
| Schedule and Public Involvement Milestones |
Date |
Related Documents |
| NRC staff develops SECY-21-0013 to request Commission approval to initiate a rulemaking to address calibration and dosage measurement for rubidium-82 generators and establish performance-based requirements for emerging medical technologies. |
February 9, 2021 |
SECY-21-0013 |
| Commission issues staff requirements memorandum (SRM) SRM-SECY-21-0013 |
January 13, 2022 |
SRM-SECY-21-0013 |
| NRC staff publishes for public comment the Regulatory Basis for “Rubidium-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material.” |
July 3, 2023 |
Regulatory Basis Document
FRN
|
| NRC holds public meeting on Regulatory Basis Document |
August 29, 2023 |
Meeting summary
Meeting transcript
NRC staff presentation
|
| End of public comment period on Regulatory Basis Document |
October 31, 2023 |
|
| Workshop on Proposed Rule |
TBD 2024 |
|
| NRC staff submits Proposed Rule to Commission |
Winter 2026 |
|
| NRC publishes Proposed Rule and draft Implementation Guidance for public comment |
TBD |
|
| Public engagement on Proposed Rule and Implementation Guidance |
TBD |
|
| NRC staff submits Final Rule to Commission |
TBD |
|
| NRC publishes Final Rule and Implementation Guidance |
TBD |
|
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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