---
kind: "section"
citation: "21 C.F.R. § 884.2800"
title: "21"
number: "884.2800"
heading: "Computerized Labor Monitoring System."
url: "https://uscodex.org/cfr/21/884.2800"
---

# §884.2800. Computerized Labor Monitoring System.

- (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)](/cfr/21/884.1.md?p=e) for availability of this guidance document.

## Notes

### Amendments

[72 FR 20227, Apr. 24, 2007]

### 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.

### Amendments

[72 FR 20227, Apr. 24, 2007]