As reported, in November 2013, the FDA already published a Draft Guidance for Industry:Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis).
Now, in autumn 2015, the CBER issued the Guidance for Industry "Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with T. pallidum (Syphilis)". The document provides updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis for establishments that make donor eligibility determinations for donors of human cells, tissues and cellular and tissue-based products (HCT/P Establishments).
This guidance finalizes the document from 2013 and supersedes the recommendations on compliance with the requirements for testing of HCT/P donors for T. pallidum infection under § 1271.80(c), that are contained in the FDA guidance entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” from August 2007. This update of the previous recommendations should clarify the expectation of the authority for an adequately and appropriately reduction of the risk of transmission of T. pallidum. That means:
To learn more about CBERs recommendation, please read the complete guidance "Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis)".