5/6 May 2021
With this draft guidance document the FDA intends to provide blood establishments collecting blood and blood components with recommendations for questioning and deferring donors of blood and blood components, allowing their re-entry, and product management to reduce the risk of transfusion-transmitted malaria. They apply to the collection of Whole Blood and all blood components with the exception of Source Plasma. Donors of Source Plasma are excluded from deferral due to malaria risk under Title 21 Code of Federal Regulations, 640.63(c)(9) (21 CFR 640.63(c)(9)).
This guidance replaces the draft guidance entitled "Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria" dated June 2000, 65 FR 36452 (June 8, 2000), (June 2000 draft guidance) (Ref. 1). When finalized, it will supersede the FDA memorandum to all registered blood establishments entitled "Recommendations for Deferral of Donors for Malaria Risk" dated July 26, 1994 (July 26, 1994 memorandum) (Ref. 2).