Category: Food and Drug Administration

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.…

USA TODAY Investigation: “Reports to Feds on deadly bacteria outbreaks arrived late”

Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might…

FDA Updates

The following lists most of the FDA’s recently issued updates, safety communications and alerts discussing the manual and automated cleaning and disinfection of side-viewing duodenoscopes (or, ERCP endoscopes). Recommendations provided…