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QUOTED. April 26, 2019. Jeff Shuren.

Executive Summary

Reports of thousands of deaths and injuries tied to the internal use of surgical staplers have spurred the US FDA to suggest tougher new regs for the devices. The move from the agency comes a month after it issued a letter to health-care providers that outlined the known risks of surgical staplers and included some safety recommendations. See what the agency's device center chief, Jeff Shuren, said about it here.

“Alerting the public and health-care professionals was an important step, but as we shared at that time, we believe additional actions must be taken to better ensure the safe and effective use of these devices.” – Jeff Shuren, director, FDA's Center for Devices and Radiological Health

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