Monday, February 15, 2021 10:37:25 PM
My expectation is that the higher court decision to RR will be based on at least in part that the current FDA guidelines are ambiguous. And as such, they require further review as it relates to what qualifies as tissue manipulation. What is it about SVF that puts it into a different classification from other tissue harvesting procedures for same surgical procedures that do not come under FDA oversight?
Dear FDA. Please explain your legal authority to single out stem cells harvested via SVF. Thank you..:)
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