12 Va. Admin. Code § 5-481-2020

Current through Register Vol. 41, No. 6, November 4, 2024

Section 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.

12 Va. Admin. Code § 5-481-2020

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; Amended, Virginia Register Volume 37, Issue 25, eff. 1/14/2022.

Statutory Authority: § 32.1-229 of the Code of Virginia.