eCFR Reference Browser

---

title: "21 CFR §315.3"

source: "https://www.ecfr.gov/current/title-21/section-315.3"

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: "315.3"

section_subject: "General factors relevant to safety and effectiveness."

cfr_reference: "21 CFR 315.3"

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"

---

FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:

(a)The proposed use of the diagnostic radiopharmaceutical in the practice of medicine,

(b)The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical), and

(c)The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.

§315.3 - General factors relevant to safety and effectiveness.