IMPORTANT NOTICE: AATB Standards are subject to revision at any time pursuant to the Association’s procedures. Such revisions may consist of the addition of a new Standard, the rescission of an existing Standard, and/or the partial amendment of a Standard. Notice of each such revision is given by AATB by posting on the Association’s website, and distributing via email, a “Bulletin” that announces those changes and their respective effective dates. Persons seeking to determine the current provisions of Standards should always review the Bulletins for any such announcement of revisions to Standards or may request a current and effective copy of the Standards by sending a request to the AATB mailbox: firstname.lastname@example.org. Please contact AATB's headquarters office for any questions concerning Standards or revisions thereof.
Published on: January 30, 2018
For the past several years, AATB and various tissue banks have had conversations with the Florida Agency for Health Care Administration (AHCA) regarding updating their regulations related to tissue banks, eye banks and organ procurement organizations (namely, 59A).
Published on: December 19, 2017
The Board of Governors acted on a recommendation from the Standards Committee and approved Guidance Document No. 10: Training and Competency.
Published on: November 30, 2017
The AATB Board of Governors acted on a recommendation from the Standards Committee and approved changes to the 14th Edition (2016) of AATB's Standards for Tissue Banking (Standards). This announcement requires your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and to educate staff.
Published on: November 17, 2017
On Thursday, November 16, the U.S. Food and Drug Administration (FDA) released two final guidance documents - one on minimal manipulation and homologous use, and one regarding the same surgical exception. The Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue- Based Products: Minimal Manipulation and Homologous Use is a guidance document intended to provide clarity on the determination of whether HCT/Ps are subject to FDA's premarket review requirements, while the Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception guidance document is intended to provide clarity as to whether an establishment may qualify for the "same surgical" exception under 21 CFR 1271.15(b).
Published on: November 01, 2017
The American Association of Tissue Banks (AATB) is pleased to announce the release of the 2nd Edition of the Standards for Non-Transplant Anatomical Donation Organizations. The Board of Governors acted on a recommendation from the Standards Committee and the Ad-Hoc NADO committee to approve the 2nd Edition Standards.