GUIDANCE DOCUMENT
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy Draft Guidance for Industry May 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2002-D-0362
- Docket Number:
- FDA-2002-D-0362
- Issued by:
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Guidance Issuing OfficeCenter 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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