HOW IS GPACT REGULATED
GPACT is a global association requiring its members to be responsible to ensure their compliance with all applicable laws and regulations regulating Colon Hydrotherapy in their area. GPACT advises colon hydrotherapists to check their local health authority, health ministry, medical board, licensing body, or health department to learn what restrictions may apply to the use of a colonic device in your area. You may find a prescription is required before the client can receive a colonic. Health and safety codes will have other information you will find useful.
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GPACT is not responsible for providing any legal information; however, as information is provided GPACT will expand this list to help colon hydrotherapists know what is required for their clinic.
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In the United States of America (USA), Colon Hydrotherapy is governed by the Food and Administration (FDA) and the Code of Federal Regulations (CFR).
COLONIC IRRIGATION SYSTEM
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2011]
[CITE: 21CFR876.5220] (source)
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TITLE 21FOOD AND DRUGS
CHAPTER IFOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER HMEDICAL DEVICES
PART 876 GASTROENTEROLOGY-UROLOGY DEVICES
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Subpart FTherapeutic Devices
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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 (876.5210).
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(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.
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(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
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(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 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.
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[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, 1996]
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