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          Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation ProceduresSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
					Guidance for Industry and Food and Drug Administration Staff
		
		May 2023


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    PrintDocket Number:
		    FDA-2022-D-0737
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health


This 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 tumor cells and other contents.


 
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						All written comments should be identified with this document's docket number: FDA-2022-D-0737.

                                                                                  Content current as of:
      05/26/2023
         
                  
Regulated Product(s)
		 Medical Devices
			  			     			  						              
			
			
			
			
			
			
			  
			  General & Plastic Surgery
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