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FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order

Executive Summary

US FDA sent the letters to

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FDA May Take Additional Regulatory Actions On Duodenoscopes, Shuren Says

The US FDA continues to find unacceptable levels of “high concern” disease-causing bacteria on duodenoscopes that have gone through cleaning and reprocessing steps, and is poised to take further action with three duodenoscope manufacturing firms to reduce patient risks.

US FDA Report Confirms Duodenoscope Contamination Risk

An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.

Warning Letter Roundup & Recap – March 13, 2018

Duodenoscope-makers Olympus, Fujifilm and Pentax Medical failed to conduct post-market surveillance study activities mandated by US FDA in 2015; quality systems violations noted at firms that make dental diagnostic X-ray devices and laser fiber-optic surgical devices. Six device-related warning letters were released by the agency this week.

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