*FDA statement on Orthobiologics – 6/3/2021*

The FDA is starting to get even more aggressive in enforcing their HCT/P regulations. The FDA statement yesterday makes it clear that what many of us have been saying for years is in fact true. #1 Stem cells, SVF, umbilical cord blood, amniotic fluid, Wharton’s Jelly, exosomes, and orthobiologics are all considered biologic drugs and ALL are improperly registered under section 361 for orthopedic applications. So, avoid using any of these products unless you are a doctor using it in an approved FDA clinical trial. …..not a company clinical trial…not your own private clinical trial…not a clinical trial just registered at clinicaltrials.gov….none of that is compliant! I am not sure what the FDA meant by including the term “orthobiologics” but it is enlightening to not that the FDA did NOT put Platelet Rich Plasma on the list and did NOT put Bone Marrow Concentrate on the list….they could have if they wanted to! If you didn’t think the Q code amniotic fluid or Wharton’s Jelly scam was dead before….boy is it now!
https://lnkd.in/eqjQ5aP