Department of Health and Human Services March 13, 2020 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised final guidance entitled ``Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry.'' The final guidance document provides blood and plasma establishments with revised recommendations related to biological product deviation (BPD) reporting. The guidance 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. The revised guidance also contains other technical updates and editorial revisions to improve clarity and provide a more streamlined document. For the purposes of this guidance, ``blood and plasma establishment'' includes licensed manufacturers of blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services. The guidance announced in this notice supersedes the document entitled ``Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments,'' dated October 2006.