§315.2. Definition.
21 C.F.R. § 315.2
For purposes of this part, diagnostic radiopharmaceutical means:
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
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 374, 379e; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).
Source
Source: 64 FR 26667, May 17, 1999, unless otherwise noted.