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

 
• By Shawn M. Schmitt

US FDA sent the letters to Olympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical after the firms failed to meet obligations to conduct Sec. 522 post-market studies on their duodenoscopes, the use of which caused a number of antibiotic-resistant superbug infections in 2013 and 2014.

Vintage inscription made by old typewriter, warning

Duodenoscope-makers Olympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical (a division of Hoya Corp.) were slapped with warning letters from US FDA today for failing to meet an agency requirement that they conduct post-market surveillance studies to ensure safe use and reprocessing of the devices they manufacture.

FDA used its authority in 2015 under Sec. 522 of the Food, Drug and Cosmetic Act to force the firms to complete studies to determine whether workers at health-care facilities...

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