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: 301-827-6220 E-mail: firstname.lastname@example.org Fax: 301-827-6748 Express mail: See address below
We will contact you 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 we require pursuant to 21 CFR 606.170(b).
Send your 7-day written report to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Director, Office of Compliance and Biologics Quality
Attn: Fatality Program Manager (HFM-650)
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448
Refer to the following documents for additional information:
- Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion: http://www.fda.gov/cber/gdlns/bldfatal.htm.
This document provides guidance on what information is helpful to us in determining potential public health significance.
- Transfusion Related Acute Lung Injury, Dear Doctor Letter:.
- Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Years 2005 and 2006