21 CFR § 315.4 - Indications.

---
identifier: "/us/cfr/t21/s315.4"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 315.4 - Indications."
title_number: 21
title_name: "Food and Drugs"
section_number: "315.4"
section_name: "Indications."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "315"
part_name: "DIAGNOSTIC RADIOPHARMACEUTICALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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)."
regulatory_source: "64 FR 26667, May 17, 1999, unless otherwise noted."
cfr_part: "315"
---


# 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.