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FDA Proposes Regulatory Changes to Improve Surgical Stapler Safety

The Food and Drug Administration recently proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices. The change would allow the agency to require premarket review of the devices and establish special controls such as mandatory performance testing of the device’s features, usability and labeling. In addition, FDA announced draft guidance to help manufacturers ensure their labeling provides adequate information for use, and a May 30 advisory committee meeting to receive expert input on the proposed reclassification and guidance. The agency has received reports of more than 9,000 serious injuries and 366 patient deaths associated with the devices since 2011, and last month issued additional safety recommendations for health care providers using the devices.

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