Description
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 updates the guidance of the same title dated September 2003.
Scope & Applicability
Product Classes
1General category for donations being tested.
Stakeholders
5A hospital oversight group that reviews and discusses fatalities.
The specific FDA role responsible for handling inquiries about reporting fatalities.
Entities that may perform testing under contract
Entity responsible for reporting transfusion-related fatalities
Entity responsible for reporting donor fatalities
Related CFR Sections (4)
- 21CFR606.170§ 606.170 Adverse reaction file.
(a) Records shall be maintained of any reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made. A written report of the investigation of aRead full regulation →
- 21CFR600.2§ 600.2 Mailing addresses.
(a) Licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER). Unless otherwise stated in paragraph (c) of this section, or as otherwise prescribed by FDA regulation, all submissions to CBER referenced in parts 600 through 680 of this chapter , as applicable, Read full regulation →
- 21CFR606.100§ 606.100 Standard operating procedures.
(a) In all instances, except clinical investigations, standard operating procedures shall comply with published additional standards in part 640 of this chapter for the products being processed; except that, references in part 640 relating to licenses, licensed establishments and submission of materRead full regulation →
- 21CFR606.151§ 606.151 Compatibility testing.
Standard operating procedures for compatibility testing shall include the following:Read full regulation →
See Also (6)
- Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff (Status: Final)
- Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
- Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products (Status: Final)
- Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS (Status: Final)
- Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for Industry (Status: Final)
- Providing Submissions in Electronic Format — Postmarketing Safety Reports (Status: Final)