Blood Donor Deferral
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:
- accurate and complete educational material for donors so that they can assess their risk;
- sensitive communication of the donor screening questions;
- donor understanding and honesty;
- quality controlled infectious marker testing procedures;
- 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. For more information see Donor deferral policy based on other potential risk factors and FDA Policy on Blood Donations from Men Who Have Sex with Other Men.
To view Public Meetings on Blood Donor Deferral (1998-2012)
Related Guidance Documents
Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry(PDF - 198KB) Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors