21 C.F.R. § 601.31 Definition.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 601—LICENSING
Subpart D—Diagnostic Radiopharmaceuticals
§ 601.31 Definition.
