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          Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical DevicesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
					Guidance for Industry and Food and Drug Administration Staff
		
		September 2018


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    PrintDocket Number:
		    FDA-2014-D-0456
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health
          Center for Biologics Evaluation and Research


The Food and Drug Administration (FDA) developed this document to provide guidance to industry and FDA staff about the appropriate use of national and international voluntary consensus standards (referred to as consensus standards) in the preparation and evaluation of premarket submissions for medical devices.


 
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						All written comments should be identified with this document's docket number: FDA-2014-D-0456.

                                                                                  Content current as of:
      09/18/2018
         
                  
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