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The Food and Drug Administration (FDA) has released revised final guidances to minimize the risk of spreading disease agents like sepsis and Mycobacterium tuberculosis through human cells, tissues, and related products. The guidances originally advised establishments to implement recommendations within four weeks, but now suggest a longer timeframe until May 4, 2025, to allow for further review and consideration of public comments. These changes follow a presidential directive for regulatory review, prioritizing public health while seeking further input. The FDA emphasizes that these updates are being implemented immediately, even as they remain open to additional public comments.

The Food and Drug Administration (FDA) has released new guidance aimed at reducing the risk of disease transmission caused by sepsis in human cell and tissue products. This guidance is designed to help organizations that make donor eligibility decisions by recommending practices to lower infection risks. The FDA issued this guidance immediately due to urgent health concerns, updating previous recommendations from 2007. The guidance reflects the FDA's current viewpoints but does not impose any legal obligations.