21 CFR 892.5740 - Radionuclide teletherapy source.

Regulations last checked for updates: Apr 30, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart F [§ 892.5050 - § 892.5930]

§ 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]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

cite as: 21 CFR 892.5740