21 CFR 884.2675
§ 884.2675 Fetal scalp circular (spiral) electrode and applicator.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.2675, § 884.2675 Fetal scalp circular (spiral) electrode and applicator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90803
- Permanent ID
ys:prov:90803@1- SHA-256
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Full text
(a) Identification. A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.