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          Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
					Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff
		
		March 2023


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2021-D-1149
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health


FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that were issued emergency use authorizations (EUAs) related to COVID-19 to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes.


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-1149.

                                                                                  Content current as of:
      03/27/2023
         
                  
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