FDA: Draft Guidance for Industry: Donor Testing for Evidence of Infection with Treponema pallidum (Syphilis)

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

On 5 November, the U.S. Food and Drug Administration published a Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema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:

• FDA no longer intends 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, when finalized, will apply to all HCT/Ps recovered after the date of its implementation."

The complete draft can be found here.