Requirements for testing human blood donors for evidence of infection due to communicable disease agents. Final rule

The Food and Drug Administration (FDA) is revising the general biological product standards applicable to human blood and blood components by updating the hepatitis B virus (HBV) and human immunodeficiency virus (HIV) testing requirements, by adding testing requirements for hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), and by adding requirements for supplemental (i.e., additional, more specific) testing approved for such use by FDA when a donation is found to be reactive for any of the required screening tests for evidence of infection due to communicable disease agents. The agency also is requiring manufacturers of certain test kits to use reference panels, when available, to verify the acceptable sensitivity and specificity of each lot. This final rule is intended to help protect the safety and ensure the quality of the Nation's blood supply, to enhance the safety of medical devices containing blood or blood components, to provide FDA with clear enforcement authority, and to promote consistency in the industry. Elsewhere in this issue of the Federal Register, FDA is publishing a rule requiring blood and plasma establishments to notify donors, including autologous donors, whenever the donor is deferred or determined not to be suitable for current or future donations of blood and blood components.