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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 315.3: General factors relevant to safety and effectiveness.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER D—DRUGS FOR HUMAN USE
  4. PART 315—DIAGNOSTIC RADIOPHARMACEUTICALS

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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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