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Medical Devices / Regulatory Affairs

FDA to Release Surgical Stapler Draft Guidance

March 12, 2019
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The FDA premised to issue draft guidance on surgical staplers and implantable staples as reports of nasty side effects continue to mount.

The agency said it wants manufacturers to include labeling to improve the safety record of the devices that have become common in surgery.

Between 2011 and 2018, medical stapes have been associated with 41,000 adverse events, including 366 deaths and more than 9,000 serious injuries, the FDA said in a letter to health care providers.

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