14/15 December 2023
On 5 November, the U.S. Food and Drug Administration published a Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema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).
In its introduction the FDA clarifies:
"This guidance updates previous recommendations contained in the 2007 Donor Eligibility guidance concerning donor testing for evidence of infection with T. pallidum and clarifies the type of tests FDA considers appropriate to adequately and appropriately reduce the risk of transmission of T. pallidum. We are providing this clarification to assist HCT/P Establishments in complying with the requirements under 21 CFR Part 1271, subpart C, for donor-eligibility determinations based on donor screening tests for T. pallidum. This guidance, when finalized, will supersede the earlier guidance on compliance with the testing requirements under § 1271.80(c), to the extent that the earlier guidance referred to the testing of HCT/P donors for T. pallidum infection. "
I the part "Recommendations" the authority further states:
"This guidance updates prior recommendations and clarifies that:
The complete draft can be found here.