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          Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical DevicesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
		 
			Draft Guidance for Industry and Food and Drug Administration Staff
		
		December 2023


	Download the  Draft  Guidance Document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	  	    Not for implementation.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	  	    This guidance is being distributed for comment purposes only.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** 02/20/2024
	  	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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2023-D-4395
	Docket Number:
		    FDA-2023-D-4395
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health
          Center for Biologics Evaluation and Research


FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The 2017 final guidance remains in effect until this draft guidance is finalized.

                                                                                  Content current as of:
      12/18/2023
         
                  
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				    				       				    				       Real World Data / Real World Evidence (RWD/RWE)
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