April 23, 2019

FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples.

The proposed steps include:

  • Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk).
  • Issuing guidance to help manufacturers make sure their labeling provides adequate information for use, including hazards and contraindications.
  • Holding a public meeting of the FDA’s General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee on May 30 to discuss the current pathway for marketing of the staplers and to receive input on the proposed reclassification and draft guidance.

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