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                Blood & Blood Products

Blood & Blood Products

                        Blood Grouping and Phenotyping Reagents
          Questions about Blood


                        Approved Blood Products
          Regulation of the Blood Supply Home
          Vaccines, Blood & Biologics
          Blood & Blood Products
          Questions about BloodBlood & Blood Products Questions about Blood
  
  	
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    PrintFDA is responsible for ensuring the safety of the Nation's blood supply. While a blood supply with zero risk of transmitting infectious disease may not be possible, there are several measures taken by FDA to protect and enhance the safety of blood products.

The blood safety system established by FDA is dependent upon: 1) accurate and complete educational material for donors so that they can assess their risk; 2) sensitive communication of the donor screening questions; 3) donor understanding and honesty; 4) quality controlled infectious marker testing procedures; and 5) appropriate handling and distribution of blood and blood products for patient use. Because of the improvements in donor screening procedures and the use of a variety of new tests in the last few years, the blood supply is safer from infectious diseases than it has been at any other time.

Key Resources

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
	Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry
	Bar Code Label Requirements for Blood and Blood Components Questions and Answers
	Blood Information & Recommendations - ARCHIVED
	Roche Molecular Systems COBAS Ampliscreen HBV Test Implementation Questions and Answers - ARCHIVED
	HIV Home Test Kits
	Variant Creutzfeldt-Jakob Disease (vCJD) and Factor VIII (pdFVIII) Questions and Answers
	Variant Creutzfeldt-Jakob Disease (vCJD) and Factor XI (pdFXI) Questions and Answers
	Variant Creutzfeldt-Jakob Disease (vCJD) and Plasma Derivatives Other than Factor VIII (pdFVIII) Questions and Answers

                                                                                  Content current as of:
      05/11/2023
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Blood ProductsBlood & Blood Products

          
                        Blood Grouping and Phenotyping Reagents
          Questions about Blood


                        Approved Blood Products
          Regulation of the Blood Supply
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