FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

March 15, 2018 (1:14 pm)  — The three manufacturers of duodenoscopes sold in the U.S. have not complied with the requirements of an order the FDA issued to each in 2015, according to individualized warning letters the FDA sent each Read More …

FDA Orders Endoscope Manufacturers to Perform Safety Studies

October 6, 2015 — Yesterday the U.S. Food and Drug Administration (FDA) ordered the three manufacturers of certain specialized medical endoscopes sold in the U.S. to perform “postmarket” surveillance studies.  This order was made public via a FDA News Release....

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