Food and Drug Administration Archives - Page 2 of 11 - Discussions in Infection Control

Sat. May 17th, 2025

FDA Clears the Redesigned Olympus Duodenoscope

January 15, 2016 Lawrence F Muscarella PhD

BREAKING NEWS FDA clears a modified Olympus TJF-Q180V duodenoscope FDA Press Release: “FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk” (January 15, 2016) Olympus Press…

Automated Endoscope Reprocessors Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Postmarket surveillance studies

FDA Orders Endoscope Manufacturers to Perform Safety Studies

October 6, 2015 Lawrence F Muscarella PhD

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.…

510(k) Clearances Carbapenem-Resistant Enterobacteriaceae (CRE) Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Ted Lieu USA Today

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

April 21, 2015 Lawrence F Muscarella PhD

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…

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Adverse Event Reports Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Misbranded Devices Patient Notification Warning letters (FDA)

FDA Clears the Redesigned Olympus Duodenoscope

FDA Orders Endoscope Manufacturers to Perform Safety Studies

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

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Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed

Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections

15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic

Category: Food and Drug Administration

FDA Clears the Redesigned Olympus Duodenoscope

FDA Orders Endoscope Manufacturers to Perform Safety Studies

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

You missed

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed

Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections

15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic