[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5220]

[Page 353-354]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                     Subpart F--Therapeutic Devices
 
Sec. 876.5220  Colonic irrigation system.

    (a) Identification. A colonic irrigation system is a device intended 
to instill water into the colon through a nozzle inserted into the 
rectum to cleanse (evacuate) the contents of the lower colon. The system 
is designed to allow evacuation of the contents of the colon during the 
administration of the colonic irrigation. The device consists of a 
container for fluid connected to the nozzle via tubing and includes a 
system which enables the pressure, temperature, or flow of water through 
the nozzle to be controlled. The device may include a console-type 
toilet and necessary fittings to allow the device to be connected to 
water and sewer pipes. The device may use electrical power to heat the 
water. The device does not include the enema kit (Sec. 876.5210).
    (b) Classification. (1) Class II (performance standards) when the 
device is intended for colon cleansing when medically indicated, such as 
before radiological or endoscopic examinations.
    (2) Class III (premarket approval) when the device is intended for 
other uses, including colon cleansing routinely for general well being.
    (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 colonic 
irrigation system described in paragraph (b)(2) of this section 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 
colonic irrigation system described in

[[Page 354]]

paragraph (b)(2) of this section that was in commercial distribution 
before May 28, 1976. Any other colonic irrigation system shall have an 
approved PMA in effect before being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 
FR 50707, Sept. 27, 1996]