Ohio Admin. Code 3701:1-58-53 - Use of sealed sources and medical devices for diagnosis
(A)
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.
(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 (IDE) application accepted by the United States food and drug
administration provided the requirements of paragraph (A) of rule
3701:1-58-17
of the Administrative Code are met.
Replaces: 3701:1-58-53
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005
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