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          Use of Real-World Evidence to Support Regulatory Decision-Making for Medical DevicesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices 
					Guidance for Industry and Food and Drug Administration Staff
		
		August 2017


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2016-D-2153
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health


FDA is issuing this guidanceto clarify how we evaluate real-world data to determine whetherthey aresufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. This guidance is applicable to all devices, as that term is defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), including software that meets the definition of a device.


 
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						All written comments should be identified with this document's docket number: FDA-2016-D-2153.

                                                                                  Content current as of:
      09/17/2018
         
                  
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