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Are PRP & MFAT FDA-Approved?

Samuel G Oltman, ND, RMSK

PRP & MFAT are not FDA-approved because they are outside of the FDA’s scope to approve– they aren’t drugs. The FDA doesn’t regulate the practice of medicine, they regulate drugs and devices. This can be a confusing subject but an important one to get an understanding of for patients considering these treatments. The question with orthobiologics (like PRP and MFAT) seems to always come back to: is your own tissue a drug product?


PRP is exempt from regulation because it’s an autologous (from your own body) blood product, as outlined in the FDA's 21 CFR 1271 of the Code of Regulations. PRP will never be approved by the FDA under this provision because it’s not considered a drug. It’s not that it is waiting to be approved or is unapproved– it is simply outside the FDA’s approval scope. 

There are FDA-approved devices for making PRP, but that is different from PRP itself being approved. We make our PRP manually and test every batch so we have maximum control over the process. This requires that we follow strict clean tissue handling processes in our in-house lab. We are able to make better quality PRP this way, and ensure your platelet count is high every time. 


MFAT is also exempt from FDA approval under the same day surgical exemption within the same FDA's 21 CFR 1271 of the Code of Regulations. If it’s from your own body, minimally manipulated, and used on your own body on the same day, it’s not for the FDA to approve because it’s not a drug. 

FTC & "Stem Cells"

The FTC also has a role in this as to what claims are marketed to patients. There are no cures for osteoarthritis. There are no orthobiologic treatments that can be marketed as cures or treatments for anything at this point.

We are not a “stem cell clinic” and we don’t do “stem cell therapy”. We are a sports medicine clinic that utilizes PRP & MFAT within a broader scope of non-surgical options. That’s why our website looks the way it does. We don’t advertise specific claims. We offer expertise. 

Fetal Tissue

Umbilical, amniotic, and fetal tissue products do not fall under any exemptions and are considered a drug, fully under FDA scrutiny. If someone in the United States is offering you these treatments, they are being misleading and deceitful. Clinics that offer these products in other countries are also dubious. There is no evidence to show that what is in those vials being sold to you have any living cells in them at all.

The only way to know you are getting quality medicine is for it to be from your own body. This is medically reputable, fully legal, and supported by emerging, albeit imperfect, evidence. It is up to you and your doctor to make the best treatment decision for you. At Cascade Regenerative Medicine, we don’t sell you treatments, we fully explain all your treatment options in detail and allow for you to make the best decision for yourself. In the field of regenerative medicine, transparency is crucial and that’s what you get with us from the moment you contact us. See the difference today.


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