21 CFR § 892.5740 - Radionuclide teletherapy source.

---
identifier: "/us/cfr/t21/s892.5740"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.5740 - Radionuclide teletherapy source."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.5740"
section_name: "Radionuclide teletherapy source."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
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. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 892.5740 Radionuclide teletherapy source.

(a) *Identification.* A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]