FDA 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.

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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