StacksVerified U.S. regulatory reference

21 CFR §315.3

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:
  1. (a)The proposed use of the diagnostic radiopharmaceutical in the practice of medicine,
  2. (b)The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical), and
  3. (c)The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.