Guidance for Treponema pallidum Screening of donors of Human Cells and Tissues (HCT/Ps)

As reported,  in November 2013, the FDA already  published a Draft Guidance for Industry:Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema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:

  • "FDA no longer intend to exercise enforcement discretion with respect to the use of diagnostic tests for evidence of infection with T. pallidum for use as HCT/P donor screening tests. Rather, we intend to enforce the requirements provided under
    § 1271.80(c) that establishments must use appropriate FDA-licensed, approved, or cleared donor screening tests in accordance with the manufacturer’s instructions to adequately and appropriately reduce the risk of transmission of disease agents such as T. pallidum.
  • Pre-amendments devices are not acceptable for use as a donor screening test for evidence of infection with T. pallidum.
  • This guidance applies to all HCT/Ps recovered after the implementation date of this guidance."

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)".

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