Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Guidance for Industry and Food and Drug Administration Staff; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance entitled "Surgical Staplers and Staples for Internal Use--Labeling Recommendations." FDA is issuing this guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths.
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