[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2800]

[Page 455]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884_OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart C_Obstetrical and Gynecological Monitoring Devices
 
Sec. 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 Sec. 
884.1(e) for availability of this guidance document.

[72 FR 20227, Apr. 24, 2007]