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Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy Draft Guidance for Industry May 2022


Not for implementation.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This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2002-D-0362

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Guidance Issuing Office
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.


Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
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(240) 402-8010
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