Bulletin: #14-5

March 13, 2014

AATB Alert Regarding Form FDA 3356

The AATB Executive Office has been notified of confusion surrounding Form FDA 3356 used for annual registration and listing for a tissue establishment with the Food and Drug Administration (FDA).

Per inquiry from AATB, FDA advised to "Please disregard the expiration date as the date is for the form and not the registration itself."

Properly registered tissue establishments are being questioned by personnel at health care facilities regarding the expiration date that appears on Form FDA 3356 in the upper right hand corner of the Form. This causes problems because an expiry is used that equates to the last day of the first month of every current year. This makes it inappropriately appear that the current registration expires quickly in the new year.

This snapshot depicts the issue:

If you have any questions, contact Scott Brubaker, Chief Policy Officer.

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American Association of Tissue Banks

8200 Greensboro Drive, Suite 320 McLean, VA 22101

Phone: 703-827-9582 | Fax: 703-356-2198 | Email: AATB@aatb.org

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.