21 CFR 884.2800
§ 884.2800 Computerized Labor Monitoring System.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.2800, § 884.2800 Computerized Labor Monitoring System, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90809
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Full text
(a) Identification. A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.
(b) Classification. Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.