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Zdrowie i gospodarka · 24.04.2019

Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Surgical Staplers and Staples for Internal Use--Labeling Recommendations." FDA is issuing this draft guidance to provide labeling recommendations for surgical staplers and staples for internal use.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. This draft guidance is not final nor is it currently in effect.

Source: Federal Register — Food and Drug AdministrationOpen original release →