21 CFR 315.4
§ 315.4 Indications.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 315.4, § 315.4 Indications, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86409
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Full text
(a) For diagnostic radiopharmaceuticals, the categories of proposed indications for use include, but are not limited to, the following:
(1) Structure delineation;
(2) Functional, physiological, or biochemical assessment;
(3) Disease or pathology detection or assessment; and
(4) Diagnostic or therapeutic patient management.
(b) Where a diagnostic radiopharmaceutical is not intended to provide disease-specific information, the proposed indications for use may refer to a biochemical, physiological, anatomical, or pathological process or to more than one disease or condition.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.