eCFR Reference Browser

---

title: "21 CFR §892.5730"

source: "https://www.ecfr.gov/current/title-21/section-892.5730"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "892"

part_subject: "RADIOLOGY DEVICES"

subpart_code: "F"

subpart_subject: "Therapeutic Devices"

section_number: "892.5730"

section_subject: "Radionuclide brachytherapy source."

cfr_reference: "21 CFR 892.5730"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

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)Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

(b)Classification. Class II.

§892.5730 - Radionuclide brachytherapy source.