Guidance for Screening and Testing of Donors of Human Tissue Intended for Transplantation; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Screening and Testing of Donors of Human Tissue Intended for Transplantation.'' The purpose of the guidance document is to assist facilities involved in recovery, infectious disease testing, screening, processing, storing, or distributing human tissue intended for transplantation. The guidance document provides information on procedures and practices for donor screening and testing. FDA prepared the guidance document after receiving public input. The topics included in the guidance document were contained in a draft document ``Screening and Testing of Donors of Human Tissue Intended for Transplantation'' made available for discussion at a public workshop on human tissue held on June 20 and 21, 1995.