21CFR601.31

§ 601.31 Definition.

Regulation Text

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.

Authority

15 U.S.C. 1451-1561;21 U.S.C. 321,351,352,353,355,356b,360,360c-360f,360h-360j,371,374,379e,381;42 U.S.C. 216,241,262,263,264; sec 122,Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e),Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N,Pub. L. 116-94, 133 Stat. 3127.

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Related Guidelines (4)

Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies (Status: Final)
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Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications (Status: Final)
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Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (Status: Final)
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Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry (Status: Final)
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21CFR601.31 — § 601.31 Definition. | CFR Explorer | BioRegHub