FDA

With the FDA finally taking some much needed action that was delayed because of COVID, there’s some confusion about what the best in-office policy might be regarding PRP. Talk all of this over with your attorney, but here’s some documents that have been helpful to me….

A.
First of all, the FDA does NOT regulate any procedures–NONE. The FDA does not approve of cholecystectomy or hysterectomy or any other procedure because it’s not what the FDA does. So, when the someone says that the FDA has not approved of the O-Shot® or P-Shot®, they are technically correct; but it’s the same as saying the FDA has not approved Toyota Celica or of the roof or your house, it’s just not what they do! If someone criticizes your practice of doing Vampire Facelifts® by saying that it’s not FDA approved, just realize it’s an uninformed, alarmist statement.
Here’s more about the FDA not overseeing procedures<–

B.
Second, PRP is not regulated by the FDA (neither is urine, skin, or saliva).

PRP is exempt from FDA regulation and regulated solely under section 361 of the PHS Act. From the FDA’s guidance: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; then
Click on this link, then go to Page 22; then read Section V,A; you will read the following:

“This guidance also does not apply to products that fall outside the definition of HCT/P in 21 CFR 1271.3(d). For example, platelet rich plasma (PRP, blood taken from an individual and given back to the same individual as platelet rich plasma) is not an HCT/P under 21 CFR Part 1271 because it is a blood product. Accordingly, FDA does not apply the criteria in 21 CFR 1271.10(a) to PRP, and PRP is outside the scope of this guidance.”

C.
The FDA SHOULD & DOES regulate the devices we use to prepare PRP and you should be using one of those devices when you do our procedures.
Using lab equipment made to measure blood to make PRP to inject back into the body is not good medicine.

D.
We are physically adding PRP into a space to create new healthy tissue which is on label for bone and off label for other areas; this “off-label” use of the device (but not for the PRP) is supported by research in many areas of the body

(see the last 2 paragraphs of this article).<–

E.
Yes, we DO have research to back up our off-label use of PRP-preparation devices for our procedures...
O-Shot research
P-Shot research
Vampire Facelift research
PRP research (over 13,000 studies)

F.
These are PROCEDURES (not simply injecting a drug)...you’re doing hydro-dissection of tissue when you do these procedures and it’s important that the procedures be done in the correct way.
Just shooting PRP anywhere does not work. You could give morphine sub q anywhere you wish and get the same result; not so with PRP.

The FDA recently stated that on June 1, 2021 it will begin its enforcement efforts on clinics and devices companies that promote, use or sell products that go beyond their established minimal manipulation standard for Human Cells, Tissues and Cellular-based Products (HCT/P). Some regenerative medicine products in the market are being mislabeled as a homologous use tissue (361) while the FDA has clearly classified them as unapproved biologic drugs (351).

The FDA DOES classify stem cells, exosomes, amniotic fluid, and mesynchemal cells as drugs, so just don’t use them without an IND or IRB.

I hope that helps clear up the misinformation.

Best regards,

Charles

Charles Runels, MD

1-888-920-5311
Cellular Medicine Association