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GUIDANCE DOCUMENT

Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes Guidance for Industry and Food and Drug Administration Staff November 2016

Final
Docket Number:
FDA-2014-D-2153
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The objectives of this guidance document are to: 1) highlight the cross-contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes; 2) clarify terminology used to describe these devices; and 3) outline strategies to mitigate the risk of cross-contamination between patients. Flexible gastrointestinal endoscopes and accessories (including valves and other devices used for irrigation) are Class II devices, as described in 21 CFR 876.1500. FDA uses product codes to identify devices that supply endoscopic irrigation, the most common being FDF (colonoscope and accessories, flexible/rigid), FDS (gastroscope and accessories, flexible/rigid), and OCX (endoscopic irrigation/suction system). These irrigation devices may be submitted to FDA in premarket notification (510(k)) applications as part of a flexible gastrointestinal endoscope system or separately as accessories to flexible gastrointestinal endoscopes.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-2153.