[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2620]

[Page 424-425]
 
                        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. 884.2620  Fetal electroencephalographic monitor.

    (a) Identification. A fetal electroencephalographic monitor is a 
device used to detect, measure, and record in graphic form (by means of 
one or more electrodes placed transcervically on the fetal scalp during 
labor) the rhythmically varying electrical skin potentials produced by 
the fetal brain.
    (b) Classification. Class III (premarket approval).

[[Page 425]]

    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any fetal 
electroencephalographic monitor that was in commercial distribution 
before May 28, 1976, or that has, on or before December 26, 1996 been 
found to be substantially equivalent to a fetal electroencephalographic 
monitor in commercial distribution before May 28, 1976. Any other fetal 
electroencephalographic monitor shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987; 61 FR 50708, Sept. 27, 1996]