Bulletins

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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. 

Bulletin 17-6

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.​

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Bulletin 17-3

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.

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Bulletin 17-2

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.

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Bulletin 17-1

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."

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Bulletin 16-15

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).

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Bulletin 16-14

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).

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Bulletin 16-13

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").

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Bulletin 15-18

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)".

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Bulletin 12-16

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."

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Bulletin 12-11

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."

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