§884.2730. Home uterine activity monitor.
21 C.F.R. § 884.2730
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.
Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
Notes, amendments, and revision history
Amendments
[66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
Amendments
[66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021]