[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: 21CFR884.2050]

[Page 424]
 
                        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. 884.2050  Obstetric data analyzer.


    (a) Identification. An obstetric data analyzer (fetal status data 
analyzer) is a device used during labor to analyze electronic signal 
data obtained from fetal and maternal monitors. The obstetric data 
analyzer provides clinical diagnosis of fetal status and recommendations 
for labor management and clinical interventions. This generic type of 
device may include signal analysis and display equipment, electronic 
interfaces for other equipment, and power supplies and component parts.
    (b) Classification: Class III (premarket approval).
    (c) Date PMA or notice of completion of 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 October 3, 2000, for any obstetric data 
analyzer described in paragraph (a) of this section that was in 
commercial distribution before May 28, 1976, or that has been found, on 
or before October 3, 2000, to be substantially equivalent to an 
obstetric data analyzer described in paragraph (a) of this section that 
was in commercial distribution before May 28, 1976. Any other obstetric 
data analyzer described in paragraph (a) of this section shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

[65 FR 41332, July 5, 2000]