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GUIDANCE DOCUMENT

Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis Guidance for Industry September 2014

Final
Docket Number:
FDA-2003-D-0128
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, 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. Licensed blood establishments must report the implementation of the recommendations contained in this guidance in accordance with 21 CFR 601.12. For additional recommendations, see "Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture," dated July 2001.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2003-D-0128.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010