eCFR Reference Browser

---

title: "21 CFR §601.32"

source: "https://www.ecfr.gov/current/title-21/section-601.32"

title_number: "21"

volume_number: "7"

chapter_number: "Unknown"

subchapter_code: "F"

subchapter_subject: "BIOLOGICS"

part_code: "601"

part_subject: "LICENSING"

subpart_code: "D"

subpart_subject: "Diagnostic Radiopharmaceuticals"

section_number: "601.32"

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

cfr_reference: "21 CFR 601.32"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 600 to 799"

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.

§601.32 - General factors relevant to safety and effectiveness.