The FDA announced a sweeping plan to review and address the safety of surgical staplers after thousands of reports of malfunctions
In a letter sent to health care providers Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries.
"Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts," Maisel said.
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