21 CFR 601.32
§ 601.32 General factors relevant to safety and effectiveness.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 601.32, § 601.32 General factors relevant to safety and effectiveness, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88336
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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.