This is Dr. Robert McGrath and as the Medical Director of Juventix Regenerative Medical I am often asked “is this Platelet Rich Plasma protocol FDA approved?”
The US Food and Drug Administration (FDA) has the authority to regulate regenerative medical products. There is currently a great deal of misleading information circulating concerning these products.
In July 2020, The FDA issued a document regulating the use of tissue- based products. The compliance and regulatory guidance is called, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. This document, currently being enforced, stated what can and cannot be done with tissue-based products in the United States.
Anyone considering the use of anything purported to be a regenerative medicine product including stem cell products, exosome products or other products derived from adipose tissue, human umbilical cord blood, Warton’s Jelly of amniotic fluid should know:
- None of these products have been approved by the FDA to treat COVID-19 of complications related to COVID-19
- None of these products have been approved by the FDA for any orthopedic condition of disease
- None of these products have been approved by the FDA for any neurologic disorder
- None of these products have been approved by the FDA for any cardiovascular disease of pulmonary disease
The Stem Cells are regulated and approved by the FDA for use in patients with disorders that affect the production of blood but no other uses.
However, The FDA does not govern the body, body parts of body fluids. People own their own blood, urine and saliva. The FDA has no regulation over what a professional does with a patient’s own blood as these are not drugs.
In the regulatory document referenced above on page 22, section V., entitled Scope of FDA’s Regulation of HCT/P the guidance states” This guidance also does not apply to products that fall outside the definition of HCT/P in21 CFR 1271.3. 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 because it is a blood product. Accordingly, FDA does not apply the criteria in 21 CFR 1271.10 to PRP and platelet rich plasma is outside the scope of this guidance”.
The Food and Drug Administration DOES govern the devices used to prepare Platelet-Rich-Plasma.
FDA “Tissue Rules” and second section specifically states HCT/P is minimally manipulated.
Additional products that are exempt from HCT/P oversight include autologous cells or tissues that are removed from an individual and implanted into the same individual without intervening processing steps beyond rinsing, cleansing, sizing or shaping. These tissues cannot be combined with other articles and must be minimally manipulated and comply with homologous (intended) use
Juventix Regenerative Medical Platelet Rich Plasma Kits are FDA approved.
Juventix is proud to only offer products that are in compliance with existing FDA regulations and national standards of care.
Restore, Revive, Regenerate Juventix Regenerative Medical
Dr. Robert McGrath