StacksVerified U.S. regulatory reference

21 CFR §884.2730

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).