[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2685]

[Page 434-435]
 
                        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. 884.2685  Fetal scalp clip electrode and applicator.

    (a) Identification. A fetal scalp clip electrode and applicator is a 
device designed to establish electrical contact between fetal skin and 
an external monitoring device by means of pinching skin tissue with a 
nonreusable clip. This device is used to obtain a fetal 
electrocardiogram. This generic type of device may include a clip 
electrode applicator.
    (b) Classification. Class III (premarket approval).
    (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 
scalp clip electrode and applicator 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 scalp clip electrode and 
applicator that was in commercial distribution before May 28, 1976. Any 
other fetal scalp clip electrode and applicator shall have an approved 
PMA or

[[Page 435]]

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]