September 12, 2016
The Alliance delivered oral comments at the FDA's September 2016 Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products. The Alliance express concern with the narrow definition of homologous use of amnion tissue and how that will impact wound care, as there are many basic functions of amniotic tissue that should be used for wound healing. The Alliance noted that there are many significant new requirements within the minimal manipulation document which not only conflict with the homologous use document, they conflict with current regulatory language.
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