FDA Publishes Several Guidance Documents Related to Donor Eligibility Determination
This article was updated after publication to include the FDA’s revision of the final guidance documents.
The U.S. Food and Drug Administration (FDA) published six guidance documents on January 6, 2025 related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The documents, listed below, relate to donor eligibility determination and include two final and four draft documents.
Shortly after publication, on January 20, the Trump Administration published an Executive Order (EO) for a Regulatory Freeze Pending Review. Paragraph (3) of the EO advises executive departments and agencies to consider postponing any published rules that have not yet taken effect for 60 days from this date for the purpose of reviewing any questions of fact, law, and policy that the rules may raise. This includes guidance documents issued by the FDA.
In response to the EO, the FDA announced on February 3 that it revised the final documents to recommend implementation of the final guidances over a longer timeframe, by May 4. Per the FDA, “The revised implementation date will permit FDA to consider the comments received thus far prior to the implementation date. Permitting the Agency additional time to further review and consider the guidances, including comments received, as well as seek additional comments is consistent with the President’s January 20, 2025, memorandum entitled, ‘Regulatory Freeze Pending Review.'”
FACT is evaluating how to move forward appropriately in accordance with the guidance documents while also monitoring any changes made by the FDA. This includes reviewing FDA’s recommendations for donor screening and evaluation for mycobacterium tuberculosis (Mtb) and sepsis. We encourage transplant and cellular therapy programs to continue doing the same while more about the mandated implementation timeline becomes known.
FDA Guidance Documents
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Draft Guidance
