[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: 21CFR884.1600]

[Page 431]
 
                        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 B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1600  Transabdominal amnioscope (fetoscope) and accessories.

    (a) Identification. A transabdominal amnioscope is a device designed 
to permit direct visual examination of the fetus by a telescopic system 
via abdominal entry. The device is used to ascertain fetal 
abnormalities, to obtain fetal blood samples, or to obtain fetal tissue. 
This generic type of device may include the following accessories: 
trocar and cannula, instruments used through an operating channel or 
through a separate cannula associated with the amnioscope, light source 
and cables, and component parts.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (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 January 29, 1987 for any 
transabdominal amnioscope (fetoscope) and accessories that was in 
commercial distribution before May 28, 1976, or that has on or before 
January 29, 1987 been found to be substantially equivalent to a 
transabdominal amnioscope (fetoscope) and accessories that was in 
commercial distribution before May 28, 1976. Any other transabdominal 
amnioscope (fetoscope) and accessories 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 51 FR 39845, Oct. 31, 
1986]