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Latest FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k) Status Alerts

This article was originally published in The Gray Sheet

Executive Summary

FDA takes new enforcement actions against duodenoscope makers in Aug. 12 warning letters to Fujifilm Medical Systems, Hoya and Olympus Medical Systems, charging adulterations to scopes, and noting troubles with CAPAs and reprocessing validation activities. Meanwhile, Fujifilm and Hoya also received so-called "510(k) status" letters.

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