Food Drug and Cosmetic Act Archives - Discussions in Infection Control

Mon. Jul 14th, 2025

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

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

May 13, 2025 Lawrence F Muscarella PhD

Hundreds of thousands of reports from device manufacturers describing an adverse event during a recent 3-and-a-half-year period were submitted to FDA late, a March study has found, raising questions about…

Bronchoscopes Carbapenem-Resistant Enterobacteriaceae (CRE) Cystoscopes Echo-endoscopes FDA's Supplemental Measures Flexible "ENT" Laryngoscopes Food Drug and Cosmetic Act Gastroscopes

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 Lawrence F Muscarella PhD

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…

522 Order Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Duodenoscopes Food Drug and Cosmetic Act FUJIFILM MCR-1 gene Medical Device Reports (MDRs) Olympus Pentax Postmarket surveillance studies Warning letters (FDA)

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

March 15, 2018 Lawrence F Muscarella PhD

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…

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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)

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

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

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

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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 Drug and Cosmetic Act

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

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

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

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