GUIDANCE DOCUMENT
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures Draft Guidance for Industry and Food and Drug Administration Staff June 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2022-D-0737
- Docket Number:
- FDA-2022-D-0737
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides the FDA’s recommendations on non-clinical performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems and may also help manufacturers comply with the special controls related to non-clinical performance data for these devices. This guidance applies to the tissue containment systems used during a power morcellation procedure for gynecologic use and for general use and provides recommendations on (1) test methods, (2) test parameters, and (3) test acceptance criteria. The recommendations are intended to promote consistency and facilitate efficient review of gynecologic and general laparoscopic power morcellation containment systems submissions. The recommendations are being made to ensure that the non-clinical test methods can effectively identify safety issues related to damage of the tissue containment system and subsequent leakage of any cancer cells and other contents.