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: 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.
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The deadline for submission of comments for Draft Guidance Document No. 11: Creation, Retention, and Security of Images Used in Tissue Banking has been extended.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. Subject matter experts discussed these survey results and, via this document, are recommending guidance for how to address the various issues associated with the use of images in tissue banking.
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.
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Draft Guidance Document No. 11: Creation, Retention, and Security of Images Used in Tissue Banking, has been drafted and is now available for comments.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. Subject matter experts discussed these survey results and, via this document, are recommending guidance for how to address the various issues associated with the use of images in tissue banking.
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.
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: 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: October 10, 2017
As part of a notice recently issued by the FDA, the regulator clarified that the Travel Notice Posting Dates table, maintained by the CDC and used by tissue banks to identify areas with active transmission risk of Zika virus (ZIKV) in other countries as part of the donor risk assessment process, HAS NOW BEEN ARCHIVED for historical purposes.
Published on: September 18, 2017
In response to an inquiry from an accredited member organization, the U.S. Food and Drug Administration (FDA) provided the American Association of Tissue Banks (AATB) with a clarification of the requirements of Sec. 1271.210 about documentation on supplies and reagents applicable to recovery establishments working in partnership with processors.
Published on: September 07, 2017
The U.S. Food and Drug Administration (FDA) released a finalized guidance on Wednesday to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency's recommendations for complying with the requirements to investigate and report HCT/P deviations.