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 19-4

Published on: June 13, 2019

On June 12, 2019, the FDA notified the American Association of Tissue Banks (AATB) about the new TRG Rapid Inquiry Program (TRIP) page published on the FDA website.

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Bulletin 19-3

Published on: March 13, 2019

AATB has received information about two separate events that may have an impact on tissue recovery and processing establishments.

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Bulletin 19-2

Published on: March 04, 2019

On March 1, 2019, the FDA announced that the Centers for Disease Control and Prevention (CDC) has changed information on its Blood and Tissue Safety webpage used to communicate epidemiological information about Zika virus (ZIKV) to the blood and tissue collection community.

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Bulletin 18-7

Published on: June 15, 2018

This guidance updates information in the March 2016 guidance by:
providing findings from more recent epidemiological studies including impact on public health;
reporting new data that informs the potential for transmission of ZIKV;
discussing the current status of availability of ZIKV tests;
updating sexual contact risk factors;
updating when an area is considered to have an increased risk for ZIKV transmission; and
providing additional scientific references.

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Bulletin 18-6

Published on: May 29, 2018

The deadline for submission of comments for Draft Guidance Document No. 11: Creation, Retention, and Security of Images Used in Tissue Banking has been extended. Surveys conducted by the AATB revealed the increasing use of photography and digital images in tissue banking processes among accredited institutions.

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Bulletin 18-5

Published on: May 03, 2018

On May 2, 2018, the FDA posted an updated guidance outlining donor screening recommendations aimed at reducing the risk of transmission of Zika Virus by HCT/Ps.

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Bulletin 18-3

Published on: February 27, 2018

Draft Guidance Document No. 11: Creation, Retention, and Security of Images Used in Tissue Banking, has been drafted and is now available for comments. Surveys conducted by AATB revealed an increasing use of photography and digital images in tissue banking processes among accredited institutions.

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Bulletin 18-2

Published on: February 08, 2018

The AATB Board of Governors has approved revisions to the Accreditation Policies (Policies). The revised Policies are made available today and become effective in ninety (90) calendar days, on May 09, 2018. Compliance by accredited tissue establishments is expected by this date.

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Bulletin 18-1

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).

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Bulletin 17-13

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).

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