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Medical Devices / Regulatory Affairs

FDA Releases Draft Guidance on Labeling for Staplers

April 24, 2019

The FDA issued draft guidance with recommendations for the labeling of surgical staplers and staples for internal use.

The agency said it decided to address the labeling of the staplers and staples because of malfunctions and misuse that led to adverse events, including death.

The guidance 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 shouldn’t be used to staple necrotic, friable, ischemic or edematous tissues.

CDRH Director Jeffrey Shuren said the guidance will help devicemakers ensure their labeling provides adequate information on hazards, contraindications and other safety issues.

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