21 C.F.R. § 884.2730

Current through September 30, 2024
Section 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).

21 C.F.R. §884.2730

66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021
As amended at 86 FR 20283, 4/19/2021