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GUIDANCE DOCUMENT

Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus Draft Guidance for Industry September 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus

Docket Number:
FDA-2018-D-3197
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, the Food and Drug Administration (FDA), are providing you, blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV), as required under 21 CFR 610.40(e). We are also providing guidance to blood establishments on how to report the implementation of these recommendations.

 

 


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:

Division of Dockets Management (HFA- 305)
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-2018-D-3197.

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