Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures." This draft guidance document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems. This draft guidance is not final nor is it for implementation at this time.
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