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New Duodenoscope Protocols Released

 
• By Elizabeth Orr

US FDA, CDC and medical groups joined forces to develop safer handling standards for the endoscope equipment, which has been tied to infection outbreaks.

New government protocols set voluntary standards for duodenoscope surveillance sampling and culturing, and could help reduce the risk of infection tied to the devices.

US FDA announced the standards on Feb. 26. They were co-developed with the Centers for Disease Control and Prevention (CDC),...

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EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
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Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Policy & Regulation

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
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Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
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Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.