21 CFR 884.6110
§ 884.6110 Assisted reproduction catheters.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.6110, § 884.6110 Assisted reproduction catheters, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90872
- Permanent ID
ys:prov:90872@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.