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FDA Warns Three Duodenoscope Manufacturers That Skirted Postmarket Study Requirements

March 09, 2018
FDA issued warning letters to duodenoscope manufacturers Olympus, Fujifilm and Pentax for failing to comply with postmarket surveillance requirements that would help determine whether health care facilities were able to properly clean and disinfect the companies' devices, the agency announced on Friday (March 9). While all three companies tell Inside Health Policy they intend to work with FDA to resolve the issue, one noted that the infections associated with the scopes -- which originally prompted the study requirement --...

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