USA – FDA reclassifies surgical staplers, staples after review links devices to injuries and deaths

The US Food and Drug Administration (FDA) on Thursday reclassified surgical staplers and staples for internal use from Class I (general controls) to the more stringent Class II (special controls) after a 2019 review of adverse events linked the devices to reports of hundreds of deaths and thousands of injuries.

With the final reclassification order in place, surgical staplers for internal use must now undergo premarket review and will be subject to special controls before they can be marketed. Alongside the final order, FDA finalized guidance providing labeling recommendations for the devices.

FDA first proposed to reclassify the devices and issued draft guidance on their labeling in April 2019 after its review and reporting by Kaiser Health News highlighted the risks posed by the devices. The agency also convened the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss the increase in adverse events and whether the devices should be reclassified. (RELATED: FDA flags 41,000 adverse event reports linked to surgical staplers, staplesRegulatory Focus 8 March 2019; FDA proposes reclassifying surgical staplersRegulatory Focus 23 April 2019)…