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GUIDANCE DOCUMENT

Notifying FDA of Fatalities Related to Blood Collection or Transfusion Guidance for Industry September 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
2002D-0124
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This document's goal is to help you, a blood collection or transfusion facility, report fatalities related to blood and blood component (blood) collection or transfusion to us, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title dated June 2002.

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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: 2002D-0124.

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