Donor Syphilis Tests Must Be FDA-Approved

Screening cells and tissues for syphilis with diagnostic tests or devices that haven’t been licensed, approved or cleared by the FDA is no longer adequate for donor testing and won’t fulfill federal regulatory criteria (21 C.F.R. 1271.80(c)), according to an FDA guidance document released Sept. 9.

The Food and Drug Administration guidance, “Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis),” replaces an August 2007 version and provides updated recommendations concerning donor testing for evidence of infection with Treponema pallidum, the etiologic agent ...