---
kind: "section"
citation: "21 C.F.R. § 884.6110"
title: "21"
number: "884.6110"
heading: "Assisted reproduction catheters."
url: "https://uscodex.org/cfr/21/884.6110"
---

# §884.6110. Assisted reproduction catheters.

- (a) **Identification.** Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.
- (b) **Classification.** Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

## Notes

### Source

Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.

### Authority

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

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.