We, FDA, are issuing this draft guidance to receive comments on revised recommendations for evaluating donor eligibility using individual risk-based questions.  This draft guidance, when finalized will provide you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.  We are also recommending that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures.  This guidance, when finalized, will supersede the guidance entitled, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” dated April 2020, updated August 2020 (April 2020 guidance).  The recommendations contained in this draft guidance, when finalized, will apply to the collection of blood and blood components, including Source Plasma.

Questions?