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          Ethical Considerations for Clinical Investigations of Medical Products Involving ChildrenSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Ethical Considerations for Clinical Investigations of Medical Products Involving Children
		 
			Draft Guidance for Industry, Sponsors, and IRBs
		
		September 2022


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2022-D-0738
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of the Commissioner, Office of Clinical Policy and Programs, Office of Pediatric Therapeutics
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research


Clinical investigations in children are essential for obtaining data on the safety and effectiveness of drugs, biological products, and medical devices in children and to protect children from the risks associated with exposure to medical products that may be unsafe or ineffective. Children are a vulnerable population who cannot consent for themselves and who therefore are afforded additional safeguards when participating in a clinical investigation. Such safeguards are an essential requirement for the initiation and conduct of pediatric investigations as part of a medical product development program. This guidance describes the FDA’s current thinking regarding ethical considerations for clinical investigations of medical products in children.


 
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						All written comments should be identified with this document's docket number: FDA-2022-D-0738.

                                                                                  Content current as of:
      09/26/2022
         
                  
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