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Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies

This article was originally published in The Gray Sheet

Executive Summary

FDA orders three duodenoscope manufacturers – Olympus America, Fujifilm Medical Systems and Hoya Corp.'s Pentax Life Care Division – to conduct postmarket surveillance studies to better understand how the scopes are being reprocessed and how to reduce the risk of patient infection. The firms told "The Gray Sheet" that they will comply with the agency's request.


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