Emerging Medical Technologies

• NRC Review of Emerging Medical Technologies
• Manufactures: Have a New Medical Use and Looking to get Started?
• Status of NRC Review of Emerging Technologies
  • 10 CFR 35.1000 licensing guidance
  • Emerging Medical Technology Licensing Memos
• Past 35.1000 Licensing Guidance
   

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.
 

Manufacturers: Have a New Medical Use and Looking to get Started?

If you are a manufacturer or early user of a new medical use, see these frequently asked questions and answers for emerging medical technology (EMT) licensing. Frequently Asked Questions For Licensing of Emerging Medical Technologies.
 

Status of NRC Review of Emerging Technologies

The medical use of radioactive material is regulated in Title 10 of the Code of Federal Regulations (CFR), Part 35. Medical uses in 10 CFR Part 35 are divided into categories based on the type of material and the purpose of use. 10 CFR 35, Subpart K (also known as 10 CFR 35.1000), provides a licensing pathway for emerging medical technologies that are not addressed by the other categories described in 10 CFR Part 35 (i.e. 10 CFR 35 Subparts D through H) because of their unique use or other radiation safety properties, 10 CFR 35, Subpart K, or 10 CFR 35.1000.

Specifically, 10 CFR 35.1000 allows licensees to be approved for use of emerging medical technologies if the licensee has submitted the information required by § 35.12(b) through (d) and has received written approval from the NRC in a license and uses the material in accordance with the regulations and specific conditions the NRC considers necessary for the medical use of the material. The NRC publishes 10 CFR 35.1000 licensing guidance documents which contain one set of regulations and specific conditions that the NRC finds as an acceptable means of satisfying this requirement. In addition, these guidance documents contain additional guidance for use. The currently available guidance documents are found below.

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.

This page includes links to files in non-HTML format. See Plugins, Viewers, and Other Tools for more information.

Many emerging medical technologies can be licensed under current 10 CFR Part 35 Subparts and is not required to be licensed under 10 CFR 35.1000. However, as the technology is new, there are sometimes questions associated with how to license it or use it safely. Therefore, the NRC also issues licensing memos to enable efficient licensing of the new use. These are found below:

Past 35.1000 Licensing Guidance

The table below provides retired 10 CFR Part 35.1000 Licensing Guidance documents for systems no longer being commercially sold and licensed.