Administrative Code

Virginia Administrative Code
8/9/2022

Article 8. Sealed Sources for Diagnosis

12VAC5-481-2020. Use of sealed sources for diagnosis.

A. Licensees shall use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

B. A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

C. Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2030. Training for use of sealed sources for diagnosis.

Except as provided by 12VAC5-481-1780, licensees shall require the authorized user of a diagnostic sealed source for use in a device authorized under 12VAC5-481-2020 to be a physician, dentist, or podiatrist who:

1. Is certified by a specialty board whose certification process includes all of the requirements in subdivisions 3 and 4 of this section and whose certification has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page; or

2. Is an authorized user for uses listed under 12VAC5-481-1920 or equivalent NRC or other agreement state requirements; or

3. Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training shall include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity; and

d. Radiation biology; and

4. Has completed training in the use of the device for the uses requested.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022.

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.