Section 335.6010  Use of Sealed Sources for Diagnosis

a)         A licensee 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 for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but shall be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

b)         A licensee shall 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 shall 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 (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of Section 335.35 are met.

(Source:  Amended at 48 Ill. Reg. 13672, effective August 29, 2024)