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          Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
					
		
		January 2024


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  	    This guidance is being distributed for comment purposes only.
	  
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    Print**Submit Comments by** 04/29/2024
	  	Submit Comments Online
			Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. 
				If unable to submit comments online, please mail written comments to:
				Dockets Management
				 Food and Drug Administration 
				 5630 Fishers Lane, Rm 1061 
				 Rockville, MD 20852
				 All written comments should be identified with this document's docket number: FDA-2016-D-3561
	Docket Number:
		    FDA-2016-D-3561
	    	    		    Issued by:
		    Guidance Issuing Office
          Oncology Center of Excellence
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research
          Office of the Commissioner, Office of Minority Health and Health Equity
          Office of the Commissioner, Office of Women's Health
          Office of the Commissioner, Office of Clinical Policy and Programs
          Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics


The purpose of this guidance is to provide FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products.  Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to FDA.  This draft guidance revises the final guidance for industry and FDA staff entitled “Collection of Race and Ethnicity Data in Clinical Trials” issued on October 26, 2016.

                                                                                  Content current as of:
      01/29/2024
         
                  
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