21 C.F.R. § 601.33 – Indications.

(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.
(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.