AATB bulletins are related to standards changes and regulatory changes. The bulletins on this page cover regulatory issues. Bulletins related to changes in AATB's Standards are referenced under the Standards section.
Published on: December 08, 2015
In mid September, the Food and Drug Administration (FDA) issued Final Guidance for Industry titled "Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)".
Published on: October 02, 2012
In the July 10 issue of the Federal Register (77 Federal Register 40736), the Food and Drug Administration (FDA) announced the availability of a Proposed Rule titled "Unique Device Identification System."
Published on: August 03, 2012
AATB Bulletin No. 12-4 issued on April 5, 2012 alerted you to the need to file for extension of a temporary waiver with the Agency for Health Care Administration (AHCA) of the State of Florida. The expiration of the "Final Order of Temporary Waiver to Rule 59A-1.005(35)(a)2 of the Florida Administrative Code" was approaching. This part of the Rule describes a requirement for a tissue donor serology panel to include an "FDA-licensed HTLV test."
Published on: April 16, 2012
We have been communicating with officials at the Florida Agency for Health Care Administration (AHCA). It is time to submit a request for extension to the temporary waiver granted to AATB-accredited tissue banks in June of 2010 (see AATB News Release, "Florida Approves a Waiver for HTLV Testing for 24 AATB-Accredited Tissue Banks," dated June 29, 2010.
Published on: August 30, 2011
The American Association of Tissue Banks (AATB) announced today the release and publication of its "Recovery Partner Audit Tool" and "Guidance Document."
The Audit Tool and Guidance Document were developed by an AATB task force, composed of members who are subject matter experts, to assist AATB-accredited tissue banks properly audit tissue recovery partners not accredited by the AATB.