Current through September 30, 2024
Section 315.4 - Indications(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.