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Telemetric gastrointestinal capsules

This article was originally published in The Gray Sheet

Executive Summary

FDA guidance document for device 510(k)s includes patient labeling as one of seven special controls. Patients should be aware of issues of electromagnetic interference and limitations of physical activity, the Nov. 28 guidance states. Given Imaging's M2A capsule, which was approved through the de novo 510(k) process Aug. 1 after initially being designated Class III, can take roughly 24 hours to move through a patient's digestive tract (1"The Gray Sheet" July 30, 2001, p. 14)...

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