Thousands Of Deaths, Serious Injuries Spur Surgical Stapler Reg Proposals
Prompted by more than 41,000 adverse events tied to surgical staplers in less than a decade, the US FDA issued a draft guidance document on the devices and proposed an upclassification from class I to class II.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.
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A US FDA panel unanimously agreed that surgical staplers should be reclassified into class II on 30 May, backing FDA recommendations.
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of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
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