Guidance for Industry. Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection

摘要

We, the Food and Drug Administration (FDA), are providing you, blood and plasma establishments, with a revised list of countries that should be included in questions for identifying donors at increased risk for HIV-1 group O infection. We are also providing you with recommendations for discontinuing the use of some questions used to identify these donors and for management of donors previously deferred. This guidance supersedes the memorandum entitled Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection, dated December 11, 1996 (Ref. 1). That memorandum contained interim measures to reduce the risk of HIV-1 group O transmission by blood and blood products pending licensure of test kits specifically labeled for detection of antibodies to HIV-1 group O viruses. Now that an FDA-licensed test for detection of antibodies to HIV-1 group O viruses is available, those interim recommendations are no longer current. FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDAs 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 FDAs guidances means that something is suggested or recommended, but not required.