Guidance on Blood Donors for Autologous Use

Federal Register Notice: FDA is making available a document entitled 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 intended solely for autologous use. FDA has developed this guidance in response to questions from blood establishments on the applicability of the donor eligibility rule to autologous donations. It explains the conditions under which the agency 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. To download this guidance, click here. To view this notice, click here.