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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 Guidance for Industry October 2019

Download the Final Guidance Document Read the Federal Register Notice
Final
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. 

 

 

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Submit Comments Online

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-2018-D-3197.

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