Tenn. Comp. R. & Regs. 0400-20-07-.61 - USE OF SEALED SOURCES AND MEDICAL DEVICES FOR DIAGNOSIS
(1) A licensee must 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 must be
used in accordance with the radiation safety conditions and limitations
described in the Sealed Source and Device Registry.
(2) 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.
(3) 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 paragraph (1) of
Rule 0400-20-07-.22 are
met.
Notes
Authority: T.C.A. ยงยง 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.