Company’s sheet HCT/P products certified to be marketed in and legally exported from the US
Marietta, GA, USA – MiMedx Group, Inc., the leading regenerative medicine company utilising human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for wound care, surgical, orthopaedic, spine, sports medicine, ophthalmic and dental sectors of healthcare, announced that it 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’s AmnioFix® and EpiFix® are among the products listed. Specifically, the FDA stated “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.”
Parker H. “Pete” Petit, Chairman and CEO, said “There has been some measure of confusion in the market related to FDA’s position regarding our sheet allografts, particularly EpiFix and AmnioFix. We have stated all along that while we are in discussion with the FDA regarding our micronised allografts, the FDA has indicated that they have no issues with our sheet allografts and that they do, in fact, qualify as HCT/P’s.”
Petit continued, “As we continue to expand our international efforts, many foreign governments require a CFG or Certificate to Foreign Government. Companies request these documents from the FDA and the FDA generated the certificate. We recently received our updated certificate and felt it was appropriate to put it on our website and resolve any confusion that may exist. The statement in the certificate referenced above is very clear that the FDA considers the MiMedx sheet allografts to be regulated as HCT/P’s.”