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Vascular composite allografts to be added to OPTN final rule and federal definitions of organs

Published on: Friday, July 5, 2013

In a federal register notice published July 3, the U.S. Department of Health and Human Services announced that vascular composite allografts (VCAs) will be added to the definition of organs covered by federal regulation (the OPTN Final Rule) and legislation (the National Organ Transplant Act). This designation is effective July 3, 2014.

The announcement establishes specific criteria for body parts to qualify as VCAs. It also will make future transplants involving VCAs subject to requirements of the OPTN Final Rule, such as transplant program designation, data submission, and compliance with applicable OPTN policies and bylaws.

The ruling followed consideration of public comments to a notice of proposed rulemaking published in December 2011.