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Monday, February 15, 2021 8:23:43 AM
The FDA pivoted away from their original argument claiming the SVF process creates a drug. They are now claiming SVF manipulates the tissue so that it is no longer the same tissue being replanted back into the same patient. The FDA states the tissue is no longer homologous (having the same relation, position, or structure). The FDA's argument is full of holes as it would also have to include any and all tissue transplantation procedures currently not under guidance of the FDA. The FDA has control over things like implants or surgical equipment, but they do not decide what is acceptable medical practice nor do they determine or tissue classifications.
I have a medial background and can elaborate, but I would suggest you do some DD on your own.
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