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]

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 884 after this date.

  • 2017-01-06; vol. 82 # 4 - Friday, January 6, 2017
    1. 82 FR 1598 - Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective January 6, 2017. See further discussion in section V, “Implementation Strategy.”
      21 CFR Part 884