Catch-22: ADM and FDA Pre-Market Approval: How Can We Construct Studies?
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DOI: 10.1097/prs.0000000000009701
Abstract: As a biologic product derived from human tissue, acellular dermal matrices (ADMs) did not require pre-market approval for their initial use as a soft tissue support product. Since their first utilization in breast surgery, ADMs… read more here.
Keywords: market approval; surgery; breast; pre market ... See more keywords