[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: 21CFR884.4270]

[Page 439]
 
                        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 E--Obstetrical and Gynecological Surgical Devices
 
Sec. 884.4270  Vibratory cervical dilators.

    (a) Identification. A vibratory cervical dilator is a device 
designed to dilate the cervical os by stretching it with a power-driven 
vibrating probe head. The device is used to gain access to the uterus or 
to induce abortion, but is not to be used during labor when a viable 
fetus is desired or anticipated.
    (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 vibratory 
cervical dilator 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 vibratory cervical dilator that was in 
commercial distribution before May 28, 1976. Any other vibratory 
cervical dilator 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]