21 CFR 884.2730 - Home uterine activity monitor.

§ 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, 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).

[ 66 FR 14076, Mar. 9, 2001]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code