Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use-Compliance Policy; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a document titled ``Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use--Compliance Policy; Guidance for Industry.'' This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) intended solely for autologous use. On May 22, 2015, in order to better assure the safety of the nation's blood supply and to help protect donor health, FDA finalized its revision of the applicable requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture (``Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use'' (donor eligibility rule)). The donor eligibility rule includes requirements related to current good manufacturing practice, donation testing, donor eligibility, and donation suitability. It became effective on May 23, 2016. FDA has developed this guidance in response to questions from blood establishments concerning the applicability of the donor eligibility rule to autologous donations. The guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain donor eligibility determination requirements in collecting blood and blood components intended solely for autologous use.