US FDA Clears MiMedx to Export Allografts.
M2 PHARMA-January 7, 2016-US FDA Clears MiMedx to Export Allografts
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- US-based regenerative medicine company MiMedx Group, Inc. (NASDAQ: MDXG) has recently posted an updated "certificate to foreign government" on its website that describes all of the MiMedx sheet form allografts and the Food and Drug Administration FDA's certification that the listed products are HCT/P's, the company said.
The company's AmnioFix and EpiFix are among the products listed. Specifically, the FDA said "It is certified that the MiMedx Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) listed in the certificate to Foreign government may be marketed in, and legally exported from, the United States of America."
Further the document states, "The last inspection showed that the plant(s) at that time appeared to be in compliance with the FDA regulation Title 21, Code of Federal Regulations Part 1271."
MiMedx is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues.
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|Date:||Jan 7, 2016|
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