21 CFR 884.2800 - Computerized Labor Monitoring System.

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There is 1 rule appearing in the Federal Register for 21 CFR Part 884. View below or at eCFR (GPOAccess)
§ 884.2800 Computerized Labor Monitoring System.
(a) Identification. A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.
(b) Classification. Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.
[72 FR 20227, Apr. 24, 2007]

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-02-26; vol. 80 # 38 - Thursday, February 26, 2015
    1. 80 FR 10330 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective February 26, 2015. The classification was applicable June 6, 2014.
      21 CFR Part 884

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United States Code

Title 21 published on 2014-04-01

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

  • 2015-02-26; vol. 80 # 38 - Thursday, February 26, 2015
    1. 80 FR 10330 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective February 26, 2015. The classification was applicable June 6, 2014.
      21 CFR Part 884