StacksVerified U.S. regulatory reference

21 CFR §315.2

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
For purposes of this part, diagnostic radiopharmaceutical means:
  1. (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
  2. (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.