Category: Food Drug and Cosmetic Act

New Guidance to Prevent Other Types of Flexible Endoscopes From Transmitting Superbugs A new practice is provided to prevent contaminated gastroscopes, echo-endoscopes and other types of flexible endoscopes from infecting patients with multidrug-resistant bacteria

March 26, 2018 (updated May 16, 2018)  —  Advice for preventing flexible endoscopes from transmitting potentially life-threatening “superbugs” is the focus of new research, which provides a new clinical practice for…

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…

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. …