FDA & CDC

The FDA disclosed on Tuesday, August 20, 2019 that they had issued a warning letter on March 20th of this year. The warring letter expressed significant concerns by the FDA...

For over 25 years the Centers for Disease Control and Prevention (CDC) has been reporting that surgical infections (SSIs) are one of the leading causes of morbidity and mortality among...

How & When To Report Medical Device Problems To The FDA The FDA came into being in 1906 with the passage of the 1906 “Pure Food and Drugs Act.” The...

FDA to Leverage Standards with New 510(k) Premarket Clearance Process One of the many important tasks handled by the Food and Drug Administration is the approval of new medical devices...

Update on Scope Reprocessing Recently the FDA issued a statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated rates of duodenoscope contamination...

The FDA’s New Medical Device Safety Action Plan Throughout history, protecting patients from harm has been a primary goal of all healthcare providers. This task has become increasingly more difficult...

FDA Rejects Push for New Regulatory Action on Medical Device Service Companies The FDA recently concluded that at the present time, there simply isn’t enough evidence to justify creating and...

FDA Alert: Risk of cross-contamination from 24-hour multi-patient use endoscope connectors to healthcare facilities performing gastrointestinal endoscopy procedures (April 18, 2018) The FDA is alerting healthcare providers and facilities about the...

FDA, CDC & ASM Recommendations for Duodenoscope Surveillance The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), along with other...

FDA, CDC and ASM are Providing Recommendations for Healthcare Facilities That Choose to Implement Duodenoscope Surveillance and Culturing Webinar March 22, 2018 from 1-2:30 PM (Eastern Time) The U.S. Food...