---
kind: "section"
citation: "21 C.F.R. § 315.4"
title: "21"
number: "315.4"
heading: "Indications."
url: "https://uscodex.org/cfr/21/315.4"
---

# §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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 374, 379e; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).

### Source

Source: 64 FR 26667, May 17, 1999, unless otherwise noted.