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          Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as SterileSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
					Guidance for Industry and Food and Drug Administration Staff
		
		January 2024


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2008-D-0611
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health


This guidance document updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that we recommend sponsors include in a 510(k) submission. For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.


 
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						All written comments should be identified with this document's docket number: FDA-2008-D-0611.

                                                                                  Content current as of:
      01/08/2024
         
                  
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