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Thousands Of Deaths, Serious Injuries Spur Surgical Stapler Reg Proposals

 
• By Elizabeth Orr

Prompted by more than 41,000 adverse events tied to surgical staplers in less than a decade, the US FDA issued a draft guidance document on the devices and proposed an upclassification from class I to class II. The measures are to be discussed at a May advisory committee meeting.

surgical staple instruments

Reports of thousands of deaths and injuries tied to the internal use of surgical staplers have spurred the US FDA to suggest tougher new regs for the devices.

The proposals include a new draft guidance document, as well as a rule that would give FDA additional regulatory oversight by moving surgical staplers for internal use from...

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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• By Ashley Yeo

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