AATB is pleased to announce that we will no longer charge institutional members a supplemental fee for satellite site inspections conducted as part of the routine three-year accreditation cycle. 

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

On Friday, January 24, 2025, all seven Medicare Administrative Contractors (MACs) announced a delay in implementing final skin substitute Local Coverage Determinations (LCDs). Initially set to take effect on February 12, 2025, the implementation date has been postponed to April 13, 2025.

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 6, 2025, the FDA released six guidance documents, including two final documents: Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps (Sepsis guidance) and Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps (Mtb guidance).

AATB has led the drafting of a letter to the Department of Health and Human Services Transition Team for President-elect Donald Trump, joined by AOPO and EBAA, to urge the immediate rescission of two FDA guidance documents released on January 6, 2025.

As we begin the new year, we encourage all our members—Accredited Establishments and their employees, Self-Paying Individual Members, and Affiliate Members—to explore and maximize the many benefits your AATB membership offers.

On January 6, 2025, the FDA published 6 guidance documents that will affect AATB tissue establishments.

The US House of Representatives passed H.R. 7188, the Shandra Eisenga Human Cell and Tissue Product Safety Act, by voice vote this week. Sponsored by Reps.