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FDA issues draft guidance on labeling for surgical staplers and staples

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has published draft guidance on labeling of surgical staplers and staples for internal use, following multiple reports of patient deaths and injuries resulting from malfunction and misuse.

The draft recommends that manufacturers place visible contraindications on their products regarding their use on tissues for which stapling is overly risky, including a statement noting that the device should not be used to staple necrotic, friable, ischemic or edematous tissues.

Release of the draft guidance was pre-announced in a FDA News Release on 8 March 2019, but the draft itself did not appear until 24 April 2019. Comments on the draft are invited until 23 June 2019.

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