Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis Guidance for Industry December 2020

GUIDANCE DOCUMENT

• Docket Number: FDA-2003-D-0128
• Issued by: Center for Biologics Evaluation and Research

We, FDA, are providing you, blood establishments that collect Whole Blood or blood components, including Source Plasma, with recommendations for screening and testing of donors and management of donations based on screening tests for syphilis.  Syphilis is a relevant transfusion-transmitted infection (Title 21 Code of Federal Regulations (CFR) 630.3 (h)(1)(v)).  Licensed blood establishments must report the implementation of the recommendations contained in this guidance in accordance with 21 CFR 601.12.  

This guidance updates the guidance of the same title dated September 2014.  The September 2014 guidance finalized the draft guidance of the same title dated March 2013, and superseded the memorandum dated December 12, 1991, entitled “Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.”

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