Tissue Banking News of Interest
The following information may be of interest to AATB's membership:
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Two weeks ago, FDA issued Final Guidance for "Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 - Guidance for Industry". It finalizes the draft Guidance posted for comment during February 2015. On April 19, 2015, the AATB submitted comments from membership and most of your recommendations changed the language used in the final version. In addition, this final guidance supersedes FDA guidance dated November 2005 entitled "Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)". The new final guidance describes it is directed at tissue establishments, excepting those that handle reproductive tissue, and further clarifies that it does not apply to healthcare professionals who use tissues/cells for recipients. To fill this gap, AATB will continue to develop useful guidance for clinicians to assist with properly identifying, reporting and investigating a suspected adverse reaction involving a tissue recipient. If interested in providing time and expertise to finalize our own guidance for this important stakeholder, contact Scott Brubaker.
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Various announcements over the past few months have been issued by FDA's Center for Devices and Radiological Health (CDRH) in relation to the Unique Device Identification (UDI) System and the Global Unique Device Identification Database (GUDID). Today, new education modules were posted to the CDRH Learn website for UDI Systems.
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It was announced in mid-February at the "Final UDRAI Workshop - A New Era" that AATB has made available an online portal where suggestions for improvement can be submitted for the Uniform Donor Risk Assessment Interview (UDRAI) forms and tools. The portal can be accessed at "Submit your comments to UDRAI forms here!" but be aware that an update is pending for the AATB website which means current links may eventually change.
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This is a reminder to keep track of application deadlines for renewing a state tissue bank license. Two are highlighted. The procedure for Florida's Agency for Health Care Administration is to send a reminder by e-mail to the address of record 90 days before the expiration of a license. If an email address is not on file, a postcard is mailed. Florida statute makes it mandatory for the application to be received at least 60 (but, no more than 120 days) before the license expiration date. Information about renewing a license online is available and application forms are available for download. To renew a tissue bank license in the State of California, the Department of Public Health's Tissue Bank Licensing Section of the Laboratory Field Services Branch issues an important notice as a reminder regarding license renewal. State law [CA H&S Code �1639.2(b)] requires the application for renewal of a tissue bank license to be filed with the department not less than 30 days prior to the expiration date of the license. In order to ensure the timely arrival of a renewed license, they request that a properly completed tissue bank renewal application packet be submitted 60 to 90 days prior to your tissue bank license expiration date. By following this timeline, a renewed license will be mailed approximately 30 days prior to the expiration date. The notice included a "2016 Tissue Bank License Renewal Document Check Off List" as well as a "2016 Operations Affirmation Letter." The latter should be completed and sent to the Laboratory Field Services Branch email address.
- The New York State Department of Health website has been updated. The Wadsworth Center section contains a link to "Laws, Regulations and Standards" and to statute and regulations for Tissue Services. Part 52, Title 10 of New York Codes, Rules and Regulations for TISSUE BANKS AND NONTRANSPLANT ANATOMIC BANKS has not changed. A previous version you might have with an effective date of February 24, 2007 can continue to be used.
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American Association of Tissue Banks
8200 Greensboro Drive, Suite 320, McLean, VA 22102
Phone: 703-827-9582 | Fax: 703-356-2198 | Email: [email protected]
The American Association of Tissue Banks (AATB) -- a professional, non-profit, scientific and educational organization -- is the only national tissue banking organization in the United States. Founded in 1976, the AATB is dedicated to improving and saving lives by promoting and advancing the safety, quality and availability of donated human tissue. To fulfill that mission,
the AATB publishes standards, accredits tissue banks and certifies personnel.
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