§ 315.2 Definition.
Current through Sep 8, 2026 · Read all of Part 315
Pending amendment Link to an amendment published at 91 FR 60004, Sept. 22, 2026.
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.