21 CFR §315.4

1. (a)For diagnostic radiopharmaceuticals, the categories of proposed indications for use include, but are not limited to, the following:
   1. (1)Structure delineation;
   2. (2)Functional, physiological, or biochemical assessment;
   3. (3)Disease or pathology detection or assessment; and
   4. (4)Diagnostic or therapeutic patient management.
2. (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.