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GUIDANCE DOCUMENT

Biological Product Deviation Reporting for Blood and Plasma Establishments Guidance for Industry March 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0007
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are providing you, a blood or plasma establishment, with revised recommendations related to biological product deviation (BPD) reporting.  This guidance document is intended to assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report.  The revised guidance explains that we do not consider post donation information (PDI) events to require BPD reports.

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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-2001-D-0007.

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