FDA Guidance on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

In August 2016, the FDA published a guidance for immediate implementation on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy. After the FDA issued the Guidance for Industry "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture" in spring 2015 to better ensure the safety of the nation's blood supply and to help protect donor health, several questions from blood establishments were submitted concerning the applicability of the donor eligibility rule to autologous donations.

The new guidance document was issued as a response to these questions. It explains the conditions under which the FDA does not intend to take regulatory actions for a blood establishment's failure to comply with certain donor eligibility determination requirements in collecting blood and blood components intended solely for autologous use.

The FDA describes the background in their guideline as follows:

"A small proportion of collections of blood and blood components are intended for autologous use. In those instances, the autologous donor presents with a physician's prescription for the collection of the donor's blood for the donor's own upcoming medical (e.g., surgical) procedure. If the donor ultimately does not need the blood, blood establishments may, in some instances, use these donations for allogeneic (i.e., intended for transfusion to a recipient other than the donor) transfusions. This is referred to as "cross-over."

Blood establishments have requested clarification on certain requirements of the donor eligibility rule and the applicability of certain sections of the donor eligibility rule to the collection of blood and blood components intended for autologous use. To address these questions, the FDA has developed this guidance to clarify the Agency's policy with respect to the requirements for autologous donors of blood and blood components intended solely for autologous use, (i.e., not subject to cross-over). Specifically:

• Section III.A describes the FDA's policy with respect to requirements in 21 CFR 630.10 relating to screening autologous donors for relevant transfusion-transmitted infections (RTTI);
• Section III.B describes the FDA's policy with respect to the requirement in 21 CFR 630.15(a)(1)(ii) that the responsible physician examine the autologous donor to permit more frequent collections; and,
• Section III.C describes the FDA's policy with respect to the requirement in 21 CFR 630.20(a) that the responsible physician determine and document that the autologous donor's health permits the collection of blood and blood components.

To get more details, please read the complete guidance "Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy"