Explore the full hierarchy of this title across chapters, subchapters, and parts.
Select a part from the tree to begin
Browse chapters and parts on the left to load sections
United States • Title 21 CFR • Part 315
This part outlines the regulations for diagnostic radiopharmaceuticals, defining their scope, safety, and effectiveness evaluation criteria. It covers radiopharmaceuticals for in vivo diagnostic and monitoring use, excluding therapeutic ones. Key considerations include proposed medical use, pharmacological and toxicological activity, and radiation dose. Effectiveness is assessed by the ability to provide useful clinical information, with specific criteria for structure delineation, functional assessment, disease detection, and patient management. Safety evaluation encompasses radiation dose, pharmacology, toxicology, risks of incorrect diagnosis, adverse reactions, and human experience.
The regulations in this part apply to radiopharmaceuticals intended for in vivo administration for diagnostic and monitoring use. They do not apply to radiopharmaceuticals intended for therapeutic purposes. In situations where a particular radiopharmaceutical is proposed for both diagnostic and therapeutic uses, the radiopharmaceutical must be evaluated taking into account each intended use.
diagnostic radiopharmaceuticalFor purposes of this part, means: (a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or (b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in paragraph (a) of this section.
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.
(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.
(a) The effectiveness of a diagnostic radiopharmaceutical is assessed by evaluating its ability to provide useful clinical information related to its proposed indications for use. The method of this evaluation varies depending upon the proposed indication(s) and may use one or more of the following criteria: (1) The claim of structure delineation is established by demonstrating in a defined clinical setting the ability to locate anatomical structures and to characterize their anatomy. (2) The claim of functional, physiological, or biochemical assessment is established by demonstrating in a defined clinical setting reliable measurement of function(s) or physiological, biochemical, or molecular process(es). (3) The claim of disease or pathology detection or assessment is established by demonstrating in a defined clinical setting that the diagnostic radiopharmaceutical has sufficient accuracy in identifying or characterizing the disease or pathology. (4) The claim of diagnostic or therapeutic patient management is established by demonstrating in a defined clinical setting that the test is useful in diagnostic or therapeutic patient management. (5) For a claim that does not fall…
(a) Factors considered in the safety assessment of a diagnostic radiopharmaceutical include, among others, the following: (1) The radiation dose; (2) The pharmacology and toxicology of the radiopharmaceutical, including any radionuclide, carrier, or ligand; (3) The risks of an incorrect diagnostic determination; (4) The adverse reaction profile of the drug; (5) Results of human experience with the radiopharmaceutical for other uses; and (6) Results of any previous human experience with the carrier or ligand of the radiopharmaceutical when the same chemical entity as the carrier or ligand has been used in a previously studied product. (b) The assessment of the adverse reaction profile includes, but is not limited to, an evaluation of the potential of the diagnostic radiopharmaceutical, including the carrier or ligand, to elicit the following: (1) Allergic or hypersensitivity responses, (2) Immunologic responses, (3) Changes in the physiologic or biochemical function of the target and nontarget tissues, and (4) Clinically detectable signs or symptoms. (c)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA may require, among other information, the…
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.