21 C.F.R. § 884.2730

Current through October 31, 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