Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola VirusSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus
					Guidance for Industry
		
		January 2017


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2014-D-2175
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research


We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). We are also providing you with recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country. This guidance document applies to Ebola virus (species Zaire ebolavirus).1 The recommendations in section III. of this guidance document apply to the routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The collection of convalescent plasma from EVD survivors is addressed in section V. of this guidance document. This guidance finalizes the draft guidance entitled, “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus,” dated December 2015.


 
	Submit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2014-D-2175.



  
	Questions?

                                                                                  Content current as of:
      11/15/2018
         
                  
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Blood ProductsHealth Topic(s)
			  Blood
			    			       			    			       EbolaSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop