Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy Guidance for Industry July 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-0362
• Issued by: Center for Biologics Evaluation and Research

This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) for transfusion or for further manufacturing use, including Source Plasma.  In the final rule dated May 22, 2015 (Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (donor eligibility rule)) (Ref. 1), FDA (we) amended the regulations applicable to blood establishments for determining donor eligibility and testing blood and blood components.  The revised requirements were implemented in order to assure the safety of the blood supply and to protect donor health.  The donor eligibility rule became effective on May 23, 2016.

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