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FDA’s Power Morcellation Containment System Guidance Doc Finalized

 
• By Elizabeth Orr

The US FDA has finalized a guidance document that details performance assessment standards for power morcellation containment systems. The class II devices have been an object of special scrutiny since the agency learned that power morcellation could spread cancerous tissue throughout the body.

Olympus Bag Morcellator

Manufacturers developing containment systems for power morcellation procedures should test the “pull force” and “burst strength” of the finished containment units, the US Food and Drug Administration recommends in a 26 May final guidance document.

Those are just two of the dozen recommendations made in the 20-page document, which discusses the agency’s expectations for the non-clinical performance testing of the containment devices. Some of the...

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