Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry." The draft guidance document addresses certain regulatory requirements for determining donor eligibility that apply to blood establishments that collect blood and blood components for transfusion or for further manufacturing use, including Source Plasma. In a final rule dated May 22, 2015, FDA 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.
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