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FDA Takes Steps to Help Reduce Risks Associated With Surgical Staplers and Implantable Staples

Tuesday, March 12, 2019   (0 Comments)
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March 12, 2019, ASCA News Digest 
Via FDA News Release (03/08/19) 


Today, the U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples—common devices used in many surgeries—and to provide updated recommendations to help reduce risks associated with their use. The letter also includes information about additional actions the agency is planning in the coming months to address the devices' safety, including issuing a draft guidance with labeling recommendations for manufacturers and holding a public advisory committee meeting to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate.

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