[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2730]

[Page 418]
 
                        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. 884.2730  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]

    Effective Date Note: At 66 FR 14076, Mar. 9, 2001, Sec. 884.2730 was 
added to subpart C of part 884, effective Apr. 9, 2001.