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These devices include devices in contact with any part of the gastro-intestinal tract such as naso-gastric tubes, esophageal instruments or dilators, and devices placed in or around the stomach or intestine. Depending upon the end use, the amount of time for patient exposure will vary. Some devices in this category are considered permanent contact.
Standards and Regulation
Most gastro-intestinal devices are considered externally communicating, with the exception of those actually implanted. First consideration should be given to vertical standards (an FDA guideline or ISO standard in use for a specific device). In the absence of such guidance, ISO 10993 should be consulted to determine potential areas of concern for these devices.
Each device should be examined on it's own merits. In some cases, prior data may be available from suppliers or in the literature, or there may be efficacy or functionality testing in progress that can be used to satisfy a portion of the safety requirements.
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