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FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

 
• By David Filmore

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

Surgical Staple Instruments

Surgical staplers and staple manufacturers have a draft guidance and reclassification advisory committee meeting to look forward to in 2019 as US FDA takes a closer look at the high volume of adverse event reports that have flowed in for the devices.

The agency circulated a letter to health-care providers March 8 highlighting safety concerns based on FDA's analysis of submitted Medical Device Reports. Specifically, FDA says it has identified 366...

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