Description
The objectives of thisguidance documentare 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.
Scope & Applicability
Product Classes
7You should identify the device as reusable or reusable, after 24-hour multi-patient use
labeling should recommend a maximum number of patient uses as well as a maximum duration of use
labeling should specify that the device should be discarded after being used on one patient
A device intended for repeated use with appropriate cleaning and reprocessing.
A device intended for use on one patient during a single procedure.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Subject of the guidance regarding cross-contamination risk; The primary device type addressed in the guidance for cross-contamination risks.; Manufacturers of flexible gastrointestinal endoscopes and accessories must establish and maintain procedures
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
2Validated use life for certain consumable components.
Device used on a single patient during a single procedure
Identified Hazards
Hazards
1automated liquid handling systems can pose a risk of contamination within or between test runs
Related CFR Sections (1)
- 21CFR876.1500§ 876.1500 Endoscope and accessories.
(a) Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optRead full regulation →
Related Warning Letters (10)
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CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
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See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Suggested Format For IDE Progress Report (Status: Final)
- Design Control Guidance For Medical Device Manufacturers: Guidance for Industry (Status: Final)
- General Principles of Software Validation: Guidance for Industry and FDA Staff (Status: Final)
- Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (Status: Final)
- Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff (Status: Final)