This guidance document provides you, blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk (21 CFR 630.15(b)(8)). This guidance supersedes the guidance titled “Revised Recommendations to Replace the Risk of Transfusion-Transmitted Malaria; Guidance for Industry” dated April 2020 (April 2020 guidance). To address the urgent and immediate need for blood and blood components during the Coronavirus Disease 2019 (COVID-19) public health emergency, in April 2020 FDA (we) issued revised recommendations to reduce the risk of TTM during the public health emergency. The recommendations in the April 2020 guidance were based on the Agency’s evaluation of the available scientific and epidemiological data on malaria risk, and data on FDA-approved pathogen reduction devices. As stated in the April 2020 guidance, FDA expected implementation of the revised recommendations would not be associated with any adverse effect on the safety of the blood supply and that early implementation of the recommendations may help to address significant blood shortages that occurred as a result of the COVID-19 public health emergency. Further, the guidance explained that we expected that the recommendations set forth in the revised guidance would continue to apply outside the context of the COVID-19 public health emergency, and that FDA would replace the April 2020 guidance with an updated guidance that incorporates any appropriate changes based on public comments and our experience with implementation. Consequently, we are issuing this revised guidance. We are issuing this guidance for immediate implementation. The recommendations, which are unchanged from the April 2020 guidance, will remain in effect outside of the context of the public health emergency related to COVID-19. Although the April 2020 guidance stated that we intended to reissue the guidance within 60 days following the termination of the public health emergency, we are not delaying this issuance because the guidance represents our current thinking on the topic. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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