Code of Federal Regulations (Last Updated: April 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter F - Biologics |
Part 601 - Licensing |
Subpart D - Diagnostic Radiopharmaceuticals |
§ 601.31 - Definition.
Latest version.
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§ 601.31 Definition.
For purposes of this part,diagnostic radiopharmaceutical means:
(a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or
(b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in paragraph (a) of this section.