Navigating Regulatory Changes: AATB's Response to the FDA Guidance Documents and Executive Order

In light of recent regulatory developments, it is essential for stakeholders in the tissue banking community to stay informed about potential changes to FDA guidance documents. On January 20, the White House issued an executive order instituting a regulatory freeze that may affect the implementation of new FDA guidance regarding Mycobacterium tuberculosis and sepsis. As we navigate this evolving landscape, AATB is committed to engaging with FDA to ensure clarity and compliance. This update aims to provide insight into both the regulatory freeze and the concerns surrounding the new guidance documents, as well as to support our hospital partners and end users in addressing their inquiries. Below, we include a statement from AATB on the regulatory freeze implications, followed by a letter to assist member establishments in communicating with their stakeholders about these important changes.  
 
AATB Statement on Regulatory Freeze Executive Order 
On January 20, the White House ordered a regulatory freeze applicable to all executive departments and agencies. The order requires any new rules to be reviewed and approved by incoming department or agency heads appointed by President Trump, and notes that if a rule has already been published but is not in effect, department and agency heads are directed to “consider” a 60-day postponement to allow for public review and comment. The definition of “rule” includes guidance if it is an agency statement of general applicability, intended to have future effect on the behavior of regulated parties setting forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation. 

The second provision of the order applies to FDA’s recently published final guidance documents related to Mycobacterium tuberculosis and sepsis, which were published in Federal Register on January 7, 2025, for immediate implementation. FDA recommends implementation of these two guidance documents “as soon as feasible, but not later than 4 weeks after the guidance issue date,” which is February 3, 2025.   

Because these two final guidance documents were issued without public review and comment, AATB believes they are clear candidates for the discretionary pause suggested in the executive order. AATB hopes FDA will adopt, at minimum, a 60-day pause to allow public comment and then to revise the guidance documents based upon public input. As noted in the letter AATB sent to FDA last week, the areas needing clarity and revision in the guidance documents are such that industry adoption of the new screening and eligibility criteria in the guidance documents is not possible in their current form.  

AATB does not know if FDA will read the application of this executive order the same way as we do. AATB is actively engaging with the agency to clarify  FDA’s expectations for implementation of these guidance documents next week and will provide an update to the tissue banking community when one is available. 

Please note that until further clarification is provided, AATB inspectors will not issue nonconformances or other findings based on the final guidance documents. Individual establishments should seek legal counsel to determine how best to ensure regulatory compliance between now and February 3, 2025.

Letter to Hospital Customers 
Recognizing that hospital partners and end users may have questions about these new guidance documents, AATB is making the following letter available to member establishments. It provides background and information that can be shared with your stakeholders about the recently published FDA guidance documents concerning Mtb and sepsis.