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GUIDANCE DOCUMENT

Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS Guidance for Industry September 2003

Final
Docket Number:
2003D-0163
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document provides our revised recommendations for assessing donor suitability and blood product safety with respect to Severe Acute Respiratory Syndrome (SARS). This guidance applies to Whole Blood and blood components intended for transfusion (including red blood cells for immunization) and blood components including recovered plasma, Source Leukocytes and Source Plasma intended for use in further manufacturing into injectable products or non-injectable products. Within this document, “donors” refers to all such donors.


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: 2003D-0163.

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