Data / Federal rules / 2024-15228
Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability
The Food and Drug Administration published this final rule in the Federal Register on July 18, 2024.
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What the agency says
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 This guidance finalizes the draft guidance entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry" issued on May 24, 2022.
Key facts
- Document number
- 2024-15228
- Type
- Final rule
- Action
- Notification of availability
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- July 18, 2024
- Dates
- The announcement of the guidance is published in the Federal Register on July 18, 2024.
- Docket
- Docket No. FDA-2022-D-0362
- Code of Federal Regulations
- 21 CFR 630
- Pages
- 2
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Published in July 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.