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          Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
					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-1118
	    	    		    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 fall within certain enforcement policies issued during the COVID-19 public health emergency to transition to normal operations when the public health emergency declaration related to COVID-19 under section 319 of the Public Health Service Act ends. 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-1118.

                                                                                  Content current as of:
      03/27/2023
         
                  
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