eCFR Reference Browser

---

title: "21 CFR §315.4"

source: "https://www.ecfr.gov/current/title-21/section-315.4"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "315"

part_subject: "DIAGNOSTIC RADIOPHARMACEUTICALS"

subpart_code: "B"

subpart_subject: "Combination Drugs"

section_number: "315.4"

section_subject: "Indications."

cfr_reference: "21 CFR 315.4"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§315.4 - Indications.