---
kind: "section"
citation: "21 C.F.R. § 892.5730"
title: "21"
number: "892.5730"
heading: "Radionuclide brachytherapy source."
url: "https://uscodex.org/cfr/21/892.5730"
---

# §892.5730. Radionuclide brachytherapy source.

- (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 (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 892.9](/cfr/21/892.9.md).

## Notes

### Amendments

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

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

### Amendments

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]