21 CFR 315.3
§ 315.3 General factors relevant to safety and effectiveness.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 315.3, § 315.3 General factors relevant to safety and effectiveness, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86408
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Full text
FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:
(a) The proposed use of the diagnostic radiopharmaceutical in the practice of medicine,
(b) The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical), and
(c) The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.