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Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures. The FDA’s recommendations are to promote consistency of information in premarket submissions for laparoscopic power morcellation tissue containment systems for gynecologic and general use.
This final guidance is intended to:
- Provide information to industry about the recommendations on non-clinical test methods, test parameters, and test acceptance criteria to support premarket submissions for gynecologic and general use of laparoscopic power morcellation tissue containment systems.
- Support manufacturers in complying with special controls related to non-clinical performance data for laparoscopic power morcellation tissue containment systems for gynecologic and general use.
- Ensure the non-clinical test methods can help mitigate safety issues related to damage of the tissue containment system and subsequent leakage of cancer cells.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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