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FDA's proposed regulation of demineralized allograft bones as devices opposed by industry at public hearing.

This article was originally published in The Gray Sheet

Executive Summary

FDA REGULATION OF DEMINERALIZED ALLOGRAFT BONE PRODUCTS AS DEVICES met opposition from industry representatives at a March 17 public hearing on FDA regulation of cellular and tissue-based products. "Demineralized bone is a tissue and should be regulated as a tissue," said Richard Davey, MD, chief medical officer for the American Red Cross. "There have been no adverse events that warrant its regulation as a medical device."
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