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USFDA - Notification Process for Transfusion Related Fatalities and Donation Related Deaths

Section 606.170(b) of Title 21, Code of Federal Regulations (21 CFR 606.170(b)), requires that facilities notify the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ), as soon as possible after confirming a complication of blood collection or transfusion to be fatal. The collecting facility is to report donor fatalities, and the compatibility testing facility is to report recipient fatalities. The regulation also requires the reporting facility to submit a report of the investigation within 7 days after the fatality.

In addition, 21 CFR 640.73 requires notification by telephone as soon as possible if a Source Plasma donor has a fatal reaction which, in any way, may be associated with plasmapheresis.

To report a fatality during regular business hours, call or email our fatality program contact within the Division of Inspections and Surveillance. Outside of regular business hours, you may submit your initial notification by leaving a voice message, or sending an email or facsimile.

Voice-mail: 240-402-9160

E-mail: fatalities2@fda.hhs.gov

Fax: 301-827-0333

Express mail: See address below

FDA will contact as soon as possible to obtain more detailed information. This does not replace the 7-day written report regarding the fatality and all related information that is required pursuant to 21 CFR 606.170(b).

Send 7-day written report to:

U.S. Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993-0002