2023-11260: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures." This 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 ("tissue containment systems"). Tissue containment systems are used to enable isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy.
The agency’s own summary, as published.
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