part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
subpart_code: "C"
subpart_subject: "Obstetrical and Gynecological Monitoring Devices"
section_number: "884.2730"
section_subject: "Home uterine activity monitor."
cfr_reference: "21 CFR 884.2730"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic. The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. 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).