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: May 25, 2017
The US Food and Drug Administration (FDA) released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). The move is part of FDA's program alignment, which transitions from geographic management to FDA-regulated product type based management. "Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes.
Published on: March 13, 2017
We would like to bring to your attention important information for human cell, tissue and cellular and tissue-based product establishments regarding Zika virus. This information is posted on the FDA's web site.
Published on: January 13, 2017
Yesterday (January 12, 2017), Organ Recovery Systems, Inc. (ORS) posted a news update to their webpage regarding reports of Contaminated Organ Preservation Fluid - SPS-1®. ORS is in the process of conducting a comprehensive investigation of available information and indicated all of their customers have been notified via email.
Published on: January 04, 2017
The Food and Drug Administration (FDA) is announcing a public workshop entitled "Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products."
Published on: September 13, 2016
Yesterday, the Food and Drug Administration (FDA) released a final guidance document that describes recommendations to use a Nucleic Acid Test (NAT) for West Nile Virus (WNV) for testing, with few exceptions, living donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Published on: August 17, 2016
Today, the Food and Drug Administration (FDA) published a notice of availability of a Final Guidance Document that recommends use of an FDA-licensed nucleic acid test (NAT) for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) when testing donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Published on: July 29, 2016
We have been communicating with officials at Florida's 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 October 2014 (see AATB Bulletin #14-08, "Final Order Granted: Extension to Temporary Waiver").
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."