surgical staplers

March 28, 2019

FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers

The FDA Food and Drug Administration announced a sweeping plan on March 8, 2019, to review and address the safety of surgical staplers. 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. The FDA also acknowledged in its letter that “we are aware that many more device malfunction reports during this time frame” were submitted as “summary reports,” which go to the FDA but are not included in the public database known […]