FDA Revises Implementation Date for Sepsis and Mtb Guidance

The FDA has announced a revised implementation date of May 4, 2025, for its recently issued guidance documents:

• Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps (Sepsis guidance)
• Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps (Mtb guidance)

While the guidance documents remain final, FDA’s decision to delay implementation reflects a willingness to further review industry concerns and seek additional comments. This extension is in line with the January 20, 2025, presidential memorandum, “Regulatory Freeze Pending Review.”

AATB remains actively engaged in advocating for practical implementation timelines and a transparent public comment process. We appreciate the support of our members and industry partners in raising awareness of these challenges.

We encourage you to continue reaching out to your Congressional offices to support AATB’s request for FDA to address industry concerns and clarify aspects of the guidance documents that remain unclear. If you do, please copy Andrew Vogt, AATB’s Director of Governmental Affairs, at vogta@aatb.org.

AATB will provide further updates as they become available. Thank you for your ongoing support and advocacy.