The Department of Health and Human Services has issued a final rule regarding blood vessels that are recovered with an organ intended for use in organ transplantation.

Previously, these blood vessels were included under the definition of human cells, tissues, and cellular and tissue-based products, which fall under the jurisdiction of the Food and Drug Administration (FDA). The final rule states that blood vessels intended for use in organ transplantation will now be governed by the regulations pertaining to organs, which are administered by HRSA. The regulation of other recovered blood vessels remains unchanged.

HRSA and FDA worked together on the final rule, which is designed to eliminate the unnecessary burdens placed on organ procurement organizations (OPOs) in complying with rules from two agencies.