---
kind: "section"
citation: "21 C.F.R. § 884.2730"
title: "21"
number: "884.2730"
heading: "Home uterine activity monitor."
url: "https://uscodex.org/cfr/21/884.2730"
---

# §884.2730. Home uterine activity monitor.

- (a) **Identification.** A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.
- (b) **Classification.** Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).

## Notes

### Amendments

[66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021]

### 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

[66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021]