Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry." The 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. This guidance finalizes the draft guidance entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry" issued on May 24, 2022.