21 CFR 884.2730
§ 884.2730 Home uterine activity monitor.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.2730, § 884.2730 Home uterine activity monitor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90807
- Permanent ID
ys:prov:90807@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.