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          Digital Health Technologies for Remote Data Acquisition in Clinical InvestigationsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
					
		
		December 2023


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2021-D-1128
	    	    		    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


This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products.  DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions.  Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient.


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-1128.

                                                                                  Content current as of:
      12/20/2023
         
                  
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